Senior Quality Assurance & TPM Compliance Analyst

Validation & Engineering Group; Washington (District of Columbia); On-site; USD 110,000 - 140,000; Full time

Job summary

Validation & Engineering Group Inc. is seeking a Quality Assurance Specialist III to support TPM plants and PQA functions, coordinating QA activities and approving manufacturing directions. The Senior PQA Analyst reviews investigations, CAPAs, and annual Product Quality Reviews to ensure GMP compliance and regulatory readiness.

The role liaises with regulatory areas, TPM sites, and QA Operations, monitors changes, conducts risk analyses, and drives cross-site initiatives across global sites.

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 Exception Reports SAP and LRMS experience is highly preferred.
• Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences.
• Strong interpersonal relations communications skills Ability to effectively communicate across all levels of the organization.

Responsibilities

• Maintains an effective liaison and cooperative relationship with other Areas including but not limited Quality Regulatory Technical Supply Chain along with the TPM sites
• Ensures that bulk drug substance andor drug product production at TPM sites is performed as per current good manufacturing practices according to local procedures and as per specifications and manufacturing directions provided by QA Operations
• Ensures TPM procedures including but not limited to raw material specification product specification test methods supplier change notification shipping are in compliance with cGMP policies regulatory approvals and Quality Technical Agreement with TPM site
• Review and approve manufacturing directions to the production floor
• Provide support to PQA in global projects and events to ensure intended results are achieved; including planning risk analysis and implementation
• Ensures investigations of TPM plant events related but not limited to process laboratory raw materials are completed thoroughly and documented accurately including adequate product impact analyses and corrective and preventive action for plant events are documented
• 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 related but not limited to supplier change notifications process laboratory and regulatory submissions that impacts all sites
• Generates detailed change management plans related to TPM plants changes to ensure intended results are achieved; including planning risk analysis and implementation

Skills

Strong analytical skills

Attention to detail

Regulatory knowledge

Cross-functional collaboration

Communication across multicultural Aud

Education

Bachelor's degree preferably in Engineering or Science

Tools

SAP

LRMS

Job description

Validation & Engineering Group Inc. is seeking a Quality Assurance Specialist III to support TPM plants and PQA functions, coordinating QA activities and approving manufacturing directions. The Senior PQA Analyst reviews investigations, CAPAs, and annual Product Quality Reviews to ensure GMP compliance and regulatory readiness.

The role liaises with regulatory areas, TPM sites, and QA Operations, monitors changes, conducts risk analyses, and drives cross-site initiatives across global sites.