QA Batch Disposition

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Position Brand Description:

The (Sr.) Principal Associate/Advisor QA – Qualified for Batch Release is responsible for final disposition of Active Pharmaceutical Ingredient (API) batches.  The (Sr.) Principal Associate/Advisor – QA – Qualified for Batch Release ensures that all batches meet specifications, are manufactured in accordance with the validated process, are compliant with cGMP requirements and comply with regulatory commitments.

Key Objectives/Deliverables:

• Provide quality support of API with the focus on holistic review of key activities associated with or impacting the manufacturing processes.
• Ensure that documented checks have been completed for the Certificates of Testing, batch disposition checklist, deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
• Evaluate and disposition API batches and manufactured penultimate batches.
• Provide feedback, coaching and mentoring to QA personnel on the interpretations of Global Quality Standards and cGMPs/regulatory regulations.
• Holistically review the impact of all deviation investigations and major deviation investigations and change control with Batch Release Impact identified as “Yes” with emphasis on the cumulative impact to the product quality of batches. May involve participation on the Technical Review Boards for deviations and changes.
• Maintain awareness of internal audit findings and external regulatory agency inspections.
• May perform Stability Coordinator back-up role and have oversight of API stability program.
• Participate in the eAPR process.
• Approve Internal Release Limits for APIs.
• Provide support of internal audits and regulatory inspections.
• Review and approve documentation that supports manufacturing (e.g., deviations, changes, procedures, protocols, training documents), as applicable.
• Act as a liaison for US and OUS customers toward resolution of concerns from customers.
• Assist in the establishment and revisions of Quality Agreements with affiliates and customers.

Basic Requirements:

• GMP manufacturing knowledge and/or experience.

Additional Preferences:

• Thorough technical understanding of quality systems and regulatory requirements.
• Demonstrated coaching and mentoring skills.
• Experience in root cause analysis.
• Demonstrated application of statistical skills.
• Experience in API or finished product manufacturing, QA or Engineering.
• Experience with system and equipment qualifications.
• Knowledge of cGMPs and quality systems.
• Demonstrated strong written and verbal communications skills.
• Strong attention to detail.
• Excellent interpersonal skills and networking skills.
• Ability to organize and prioritize multiple tasks.
• Demonstrated flexibility when faced with changing priorities.
• Proficiency with computer system applications and process automation systems.

Education Requirements:

• BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences, related Life Sciences
• 3 years o GMP manufacturing knowledge and/or experience.

Other Information:

• Must complete Learning Plan for (Sr.) Principal Associate/Advisor – QA – Qualified for Batch Release – IAPI and stability program.
• No certifications required.
• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
• Must carry a cell phone to support 24 hour/day operations.

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