Position Brand Description: The API EM Quality Assurance Specialist provides support to all quality activities at Contract Manufacturing organizations (CMs).
The QA Specialist position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to c GMPs and regulatory commitments.
Key Objectives/Deliverables: Serve as a liaison between CMs and company.
Provide quality oversight of CMs including being the initial point of contact for all quality-related issues.
Escalate quality issues at CMs to company QA management.
Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
Provide quality oversight of the companys/APIEM Quality Plans Coordinate and perform QA responsibilities of API shipments.
Participate in regulatory inspection preparations with CMs.
Provide on-site support during inspections.
Participate on the Technical Review Board Evaluate and disposition API batches, if required.
Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
Provide quality support of API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures.
Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
Ensure all processes are in an appropriate state of control.
Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods, and computerized system validations.
Participate in APR activities.
Participate in projects to improve productivity.
Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.
Basic Requirements: BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences, or related Life Sciences.
Previous GMP manufacturing knowledge and/or experience in API or finished product manufacturing, QC, QA, or Engineering.
Additional Preferences: Experience in quality support for Quality Control activities Thorough technical understanding of quality systems and regulatory requirements.
Knowledge of pharmaceutical manufacturing operations.
Demonstrated coaching and mentoring skills.
Experience in root cause analysis.
Demonstrated application of statistical skills.
Demonstrated strong written and verbal communications skills.
Strong attention to detail.
Proficiency with computer system applications.
Excellent interpersonal skills and networking skills.
Ability to organize and prioritize multiple tasks.
Ability to influence diverse groups and manage relationships.
Education Requirements: BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences, or related Life Sciences.
Skills: External Manufacturing Contract Manufacturer Review Approval API