QA Chemist I

• Responsible for quality of assigned products which may include small molecule pharmaceuticals and/or combination products to ensure business objectives are met with regards to on time delivery of product while assuring compliance with local, divisional, and corporate policies and external agency regulations worldwide.

• Products include Intermediates or Drug Products produced by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships.

• Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands.

• Grade is commensurate on level of overall responsibility.

Responsibilities

• Supports the primary quality lead with management oversight for project activities at TPM and the team members (within and outside ) to achieve on-time quality deliverables. Driver for the quality and compliance aspects of product packaging transfers.

• Participates in the development of global Product Quality Assurance strategy to support pharmaceuticals, and combination products produced at third party manufacturing (TPM) facilities. Implements agreed strategy.

• Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues for sterile, liquid, solids, and/or device products and elevates medium and high risk events to management.

• Establishes and maintains relationships and open communication with Third Party Manufacturers, affiliates and other functional groups to maintain roles and responsibilities.

• Communicates and negotiates with external companies' quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide with the agreed service.

• Provides support for quality audits. Supports pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.

• Supports the management of exception documents and Corrective and Preventive Actions.

• Completes management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues. Obtains and reviews summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from the Third Party Manufacturer to ensure accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner.

Job Specific Activities/Expectations

• Batch Reviewer for lot release

• Batch Record Review Certification activites

• Raising/Participate/Drive Change Controls

• Prepare and Present Triage Slides for significant events

• Support Virtual Operations Teams

• Ensure annual stability is properly managed

• Prepare and Present Quality Revies with TPMs

• Redline/Update QTAs

• Facilitate alignment between ABV & TPM

• Support Audits

• Reivew and approve TPM PQRs and/or APRs

• Lead/Contribute to investigations at TPMs

• Support packaging transfer projects and activities at TMPs

Top 3-5 skills, experience or education required

1. Equipment Engineering

2. Validation / Qualification

3. Manufacturing

4.Packaging experience a plus

About US Tech Solutions

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ~~~.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.