Quality Assurance (QA) Specialist II

Weil Group • Barceloneta, PR

2d

About The Position

The Senior Product Quality Assurance (PQA) Analyst supports day-to-day Quality Assurance activities at Third Party Manufacturing (TPM) plants. The role includes approving manufacturing directions for production, reviewing and approving manufacturing, laboratory, and raw-material investigations, assessing product impact analyses and corrective and preventive actions, and reviewing and approving applicable changes. The analyst evaluates supplier change notifications, monitors process tracking and trending, and performs annual Product Quality Reviews. The role also serves as a liaison between company regulatory areas and TPM plants for regulatory submissions.

The position works with internal Client Areas—including Quality, Regulatory, Technical, and Supply Chain—and TPM sites to ensure production and related procedures comply with current good manufacturing practices, specifications, local procedures, regulatory approvals, company policies, and Quality Technical Agreements. It also contributes to global PQA projects and events and develops change-management plans for TPM-related changes.

Requirements

• Bachelor’s degree, preferably in Engineering or Science; the posting also mentions a BS degree and/or equivalent experience.
• Six years of experience in pharmaceutical operations, preferably in biologic manufacturing; the posting also describes an experience level of 5–7 years and separately mentions 7 years of equivalent experience.
• Knowledge of GMP regulations and standards affecting pharmaceutical products.
• Comprehensive knowledge and application of business and quality concepts.
• Strong analytical skills and attention to detail.
• Strong interpersonal and communication skills, including the ability to communicate effectively across all organizational levels and adapt communication style for different modes and multicultural audiences.
• Ability to work independently and experience with quality systems.
• Fully bilingual in English and Spanish.

Nice To Haves

• Experience with change plans, Exception Reports, SAP, and LRMS is highly preferred.
• Experience in biologic manufacturing processes.

Responsibilities

• Maintain an effective liaison and cooperative relationship with Client Areas, including Quality, Regulatory, Technical, and Supply Chain, and with TPM sites.
• Ensure bulk drug substance and/or drug product production at TPM sites follows current good manufacturing practices, local procedures, specifications, and manufacturing directions provided by Client QA Operations.
• Ensure TPM procedures—including raw-material and product specifications, test methods, supplier change notifications, and shipping—comply with cGMP, policies, regulatory approvals, and the Quality Technical Agreement with the TPM site.
• Review and approve manufacturing directions for the production floor.
• Support PQA global projects and events, including planning, risk analysis, and implementation, to help achieve intended results.
• Ensure TPM plant event investigations, including process, laboratory, and raw-material events, are thorough and accurately documented, with adequate product impact analyses and corrective and preventive actions.
• Perform annual Product Quality Reviews according to the Client global procedure and regulatory requirements.
• Participate in the Trend Review Board to monitor process tracking and trending.
• Participate in Global Change Review Board meetings as a TPM representative to evaluate global changes, including supplier change notifications and changes affecting processes, laboratories, and regulatory submissions.
• Generate detailed change-management plans for TPM plant changes, including planning, risk analysis, and implementation.
• Act as a liaison between company regulatory areas and TPM plants for regulatory submissions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level