Senior Representative, QA

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart, and lung diseases as well as Alzheimer's.

I. Department Overview:

The Quality Assurance department is responsible for all aspects of the quality assurance functions. The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients.

Quality Assurance Systems group has ownership over the quality systems, including deviations and CAPAs, change controls, document control, supplier quality management, raw material testing and disposition, and training, as well as oversight of the equipment calibration and preventive maintenance program and validation activities.

Quality Assurance Operations group has oversight of the manufacturing areas, including process technology transfer, master batch record review and approval, on-the-floor support, product disposition, and shipping.

Quality & Compliance group has oversight of internal and client audits as well as regulatory agency inspections, compliance and regulatory support initiatives, and process validation activities.

II. Functional Specific Duties, Activities, and Responsibilities:

Equipment Management

• Responsible for supporting the quality system for the calibration, preventive, and demand maintenance program and reporting associated metrics.

• Performs review of equipment calibration and preventative maintenance work orders

• Maintains the equipment master data in the Computerized Maintenance Management System (CMMS)

• Collaborates with system owners to ensure compliance of the Equipment Management System is maintained in accordance with standard operating procedures.

• Manages and maintains equipment and controlled document files.

• Reviews and approves all facility and equipment records in support of GMP operations.

• Provides formal and informal training and guidance on use of the CMMS systems.

• Provides technical assistance and training for personnel.

• Other duties as assigned.

Supplier Management

• Accountable for the incoming material inspection and disposition process.

• Collaborates with Quality Control, Materials Management and Manufacturing to ensure that suitable materials are available for use.

• Manage processing defective materials, including disposition and identification of corrective action as necessary.

• Provides support for the introduction of new materials.

• Creates, revises, and maintains material specifications.

• Support management and assessment of supplier notifications and material change requirements.

• Maintains the records pertaining the material lifecycle and lot disposition.

• Assists in the customer and supplier auditing process providing administrative support including information gathering and organization.

• Other duties as assigned.

Quality Systems and Metrics

• Accountable for the Investigation and CAPA Management Systems.

• Responsible for managing complex and high-level deviations, supporting OOS investigations, and collaboration with internal Catalent stakeholders to support the effective execution of the Investigation and CAPA systems.

• Maintains and enhances effectiveness of the Quality System, including developing and reporting metrics, identification, and implementation of improvement opportunities for established Quality Systems, processes, procedures, and training to support Deviation, Out-of-Specification and CAPA processes.

• Drives alignment and improvement initiatives, leading cross function teams, to address process improvement, system improvement, and new regulations/expectations.

• Files and maintains controlled documents.

• Other duties as assigned.

Quality and Compliance

• Participates in internal audits, including coordinating the audit with relevant department subject matter experts, performing in-depth assessments of systems and procedures, and communicating audit findings to key stakeholders.

• Supports customer audits, including co-hosting audits and providing accurate information regarding the quality systems and operations; overseeing the audit response follow up actions.

• Complete Back Room Audit Responsibilities during external audits; managing and completing requests, contacting and orchestrating Subject Matter Experts, Preparing documents into presentable format for auditors.

• Complete Front Room Audit Responsibilities during client audits; facilitate the audit in lead or support role, manage positive client relations, actively host client interactions while onsite

• Review and approve responses to audit findings

• Assists in maintaining facility licenses and registrations.

• Organizes documentation and facilitates review in support of client regulatory submissions.

• Monitors and assesses changes to regulatory guidance and compendial monographs.

• Supports and enhances effectiveness of the quality system, including reporting metrics; authoring Standard Operating Procedures (SOPs); identifying improvement opportunities; assisting with change control, risk management, and corrective and preventive action processes.

• Supports alignment and improvement initiatives, participating on cross functional teams to address process improvement, system improvement, and new regulations / expectations.

• Supports the management of customer Quality Agreements, including facilitating the development and approval of the agreements, ensuring accessibility of the agreements, and coordinating the revision and review of agreements.

• Drafts technical plans, protocols, control strategies, and reports related to process validation and process monitoring (e.g., PPQ, CPV, APR / PQR).

• Maintains statistical tools to meet requirements for system and process monitoring and review.

• Owns, maintains, and reports out Quality Key Performance Indicators (KPIs) for area of expertise.

• Maintains a sufficient understanding of the quality systems and operations.

• Lead meetings with clients and team.

• Readiness and Response: Oversight, approval and implementation for Inspection Playbook and other process improvement projects.

• Readiness and Response: Manages site Subject Matter Experts(SME) and program, including Training content and delivery

• Readiness and Response: Responsible for critical client and regulatory audit outputs, including; audit response review and management and SME follow Ups.

• Internal: Perform Risk Assessment on facility areas annually

• Internal: Create Audit Schedule, and adhere to audit schedule

• Files and maintains controlled documents.

• Other duties as assigned.

On-Floor Support

• Accountable for execution of the QA on the Floor program.

• Partner with Manufacturing and other support teams.

• Performs on the floor activities supporting client projects, including room release, observing critical processes, reviewing batch documentation in real time, cleaning documentation, logbooks and resolving issues that occur during manufacturing.

• Perform Acceptable Quality Limit (AQL) visual inspection of drug product.

• Review and approve batch documents.

• Generate or revise GMP documentation such as Standard Operating Procedures, Master Batch Record review, etc.

• Compile deviations as required when observed on the floor and move to completion within the required time frame.

• Serves as delegate to Department Supervisor / Manager.

• Initiate deviations as required when observed on the floor.

• Provides dedicated quality floor oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product - 50% of day is spent on the floor.

• Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices.

• Provides QA support and escorting of Client Person in Plant (PIPs).

• Act as QA reviewer for deviations and CAPA issuance.

• Make solid quality decisions without oversight.

• Ability to assess and triage deviations that occur within the local process team.

• Identify and implement continuous improvement initiatives.

• Participate in site and corporate quality and process improvement initiatives.

• Represent QA on project teams and represent QA perspective as necessary.

• Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices.

• Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.

• Assists and train colleagues on aseptic behavior, techniques, and best practices.

• Continuously observe and review aseptic practices on the manufacturing floor as applicable to each manufacturing suite.

• Provide immediate feedback during routine observation to line leaders and colleagues, both positive practices and opportunities for improvement to allow for further development of colleague capabilities.

• Assign feedback in the form of a visual indicator to the aseptic performance on the line.

• Observe aseptic process performance to support efficient and effective process operations. Make recommendations to continuously improve aseptic manufacturing processes and systems.

• Observe aseptic technique during validation media fill simulations.

• Observe, coach and continuously improve knowledge of microbiological science, microbiological control strategies, microbiological/environmental monitoring program and how each impact aseptic processing.

• Provide SME knowledge of aseptic practices within the site cleanrooms.

• Evaluate aseptic processes during validation smoke studies

• Serve as an active member of investigations team during activities related to environmental events.

• Analyze, develop, and improve quality systems and associated business processes to achieve compliance with global regulatory requirements.

• Support investigation activities utilizing root-cause and problem-solving methodologies, including support of CAPA development and implementation.

• Develop and maintain department and site metrics for monitoring critical process and Quality attributes.

• Review and approve appropriate technical documentation in support of cross-functional and cross-departmental projects.

• Promotes teamwork, a positive work environment and an atmosphere that enhances continuous improvement in aseptic quality and production environment.

• Demonstrate and promote a "Right the First Time" culture, while operating in a safe manner, elevating all safety issues and concerns appropriately and in a timely manner.

• Follow all SOPs, cGMPs, batch records, and remain current with all training requirements.

• Other duties as assigned.

Product Quality

• Accountable for review and approval of project related documents such as Master Batch Production Records, technical transfer, and process characterization reports.

• Responsible for final approval and disposition of finished product for shipment to customers.

• Responsible for representing Quality Assurance as the primary contact for assigned projects, which includes cross functional internal and external collaboration, supporting integration of the client programs into the Catalent Quality Management System and ensuring effective management of client expectations.

• Responsible for interfacing with the clients and managing internal communication to sustain and enhance the Client quality relationships,

• Accountable for review and approval of project related deviation investigation records.

• Accountable for ensuring that Finished Products are manufactured and tested in a manner consistent with the applicable regulatory or client requirements.

• Maintains a sufficient understanding of the quality systems and operations to provide consultation and guidance for Manufacturing personnel regarding execution of the Quality Management Systems.

• Supports execution of QA on the Floor program.

• Supports issuance of controlled documents for production, including Batch Production Records, Product Labels, and forms.

• Assists with inspection of final product containers

• Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.

• Other duties as assigned.

Batch Review / Disposition

• Responsible for final approval and disposition of finished product for release to customers.

• Accountable for ensuring that Finished Products are manufactured and tested in a manner consistent with the applicable regulatory or client requirements.

• Maintains a sufficient understanding of the quality systems and operations to provide consultation and guidance for Manufacturing personnel regarding execution of the Quality Management Systems.

• Develops and provides training to support the training program for QA and manufacturing on specific quality functions.

• Supports and enhances effectiveness of the quality system, which may include: reporting metrics; developing, authoring and approving Standard Operating Procedures (SOPs); identifying improvement opportunities

• Provide program specific review of documents supporting process validation and regulatory filings.

• Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.

• Performs and supports any other tasks necessary to maintain the product quality and site cGMP compliance.

• Other duties as assigned.

III. Position Requirements:

Education/Experience:

• STEM Bachelor's degree, highly preferred

• 5-8 years of relevant experience with Bachelor's degree, required

• 8+ years of experience or demonstrated excellence in role with justification

• Min of 2 years GxP experience or other regulated industry

• Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies.

• Strong analytical and problem-solving abilities. Capable of making decisions using experience along with site process and procedures.

• Robust interpersonal skills, organizational skills, and project management skills, with the ability to balance multiple priorities and projects.

• Must be able to read and understand English-written job instructions and safety requirements.

• Prior experience working in and/or supporting aseptic operations in a cGMP environment as it relates to cleaning and sanitization, regulatory (worldwide), deviation investigation, product and process validation, environmental testing, and investigations, preferred.

• A strong working knowledge of quality systems and processes, preferred.

IV. Dimensions of Position:

Scope of Responsibility:

• Reports to: Supervisor or above

• Direct Reports: N/A

V. Physical, Safety and Behavioral Requirements of the Position:

Technical Requirements:

• Ability to use Excel, Word, and other office systems.

• Ability to learn and use quality management software such as TrackWise® or ComplianceWire®.

• Ability to understand and independently apply CGMPs to everyday work.

• Demonstrates understanding of the work tasks assigned.

• Executes procedures of moderate complexity with high quality.

• Intermediate understanding of pharmaceutical laboratory and/or production operations.

• Capable of learning unfamiliar principles or techniques with training.

• Ability to contribute to investigations, deviations, and change controls with initial consultation from supervisor.

• Ability to problem solve and execute and monitor corrective actions.

• Ability to interpret data and analyze trends and provide insight into potential issues and suggest solutions.

• Edits Standard Operating Procedures (SOPs) and reports with guidance from supervisor.

• Seeks best practices for daily work activities.

Behavioral Requirements:

• Ability to see and hear and read and write clear English.

• Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner.

• Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time.

• Ability to cooperate with coworkers within an organized team environment or work alone.

• Detail oriented and well organized with ability to work effectively under high pressure with multiple deadlines.

• Ability to put aside personal opinions and focus on business needs, department needs or group needs.

• Ability to transfer knowledge to others via training or mentoring.

• Demonstrated ability to guide others thorough communication and learning.

• Ability to make decisions which have moderate impact on immediate work unit.

Leadership Requirements:

• Lead by example according to Catalent's values and culture.

• Builds on contacts and relationships with peers.

• Take initiative for personal and professional development.

• Takes initiative when necessary to address changes in scope and procedural errors.

• Builds trust and respect for self and department.

Safety and Environmental Requirements:

• Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.

• Occasional stooping, kneeling, crouching, bending, carrying, grasping.

• Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.

• Must comply with EHS responsibilities for the position.

• Working conditions will be Heating Ventilation and Air Conditioned controlled.

• Ability to operate within a clean room environment as needed.

• Walking and/or standing for up to 8 to 12 hours depending on assigned area.

• Successful completion of gowning certification to enter and support the aseptic manufacturing areas.

Business Environment:

• Fast-paced

• Performance driven

• Customer focused

• Collaborative and inclusive

• Team player

About Catalent:

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent is headquartered in Somerset, N.J. For more information, visit ~~~ .

More products. Better treatments. Reliably supplied.

To perform this job successfully, an individual must be able to perform each duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This job description reflects the general duties of the job but is not a detailed description of all duties which may be inherent to this position. Catalent may assign reasonably related additional duties to individual employees, consistent with company policy.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (~~~) to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to ~~~ . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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