Senior Quality Assurance Analyst — Pharma & TPM Compliance

Pinnaql; Washington (District of Columbia); On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group Inc, a Pinnaql company, seeks a Quality Assurance (QA) Specialist III to join the team and support day-to-day QA activities for TPM plants within pharmaceutical manufacturing operations.

The Senior PQA Analyst will review and approve manufacturing directions, investigate QA events, monitor product quality, and participate in global governance boards, ensuring compliance with cGMP and regulatory requirements.

Qualifications

• Bachelor's degree preferably in Engineering or Science.
• Six years of experience within the Pharmaceutical operations preferably Biologic manufacturing process.
• 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.
• Change plan, SAP and LRMS experience is highly preferred.

Responsibilities

• Maintains an effective liaison and cooperative relationship with other Areas including Quality, Regulatory, Technical, Supply Chain, along with the TPM sites.
• Ensures that TPM production at TPM sites is performed as per current good manufacturing practices and QA directions.
• Ensures TPM procedures including raw material specification, product specification, test methods, supplier change notification, shipping are in compliance with cGMP policies and QA agreements with TPM site.
• Review and approve manufacturing directions to the production floor.
• Provide support to PQA in global projects and events, including planning risk analysis and implementation.
• Ensures investigations of TPM plant events are completed thoroughly and documented with adequate product impact analyses and CAPA.
• Perform annual Product Quality Review according to global procedure to comply with regulatory requirements.
• Participates in Trend Review Board to monitor process, track, and trending.
• Participates in the Global Change Review Board (GCRB) meeting as TPM representative to evaluate global changes impacting sites.
• Generates detailed change management plans related to TPM plants changes to ensure intended results, including planning, risk analysis and implementation.

Skills

Analytical skills

Attention to detail

Interpersonal skills

Communication across levels

Education

Bachelor's degree in Engineering or Science

Tools

SAP

LRMS

Job description

Validation & Engineering Group Inc, a Pinnaql company, seeks a Quality Assurance (QA) Specialist III to join the team and support day-to-day QA activities for TPM plants within pharmaceutical manufacturing operations.

The Senior PQA Analyst will review and approve manufacturing directions, investigate QA events, monitor product quality, and participate in global governance boards, ensuring compliance with cGMP and regulatory requirements.