Job Role- QA Deviation

Employment Type-6+month contract

Pay rate-$50-75/hr

Location-Norwood, MA

Here’s What You’ll Do:

• Write, review and approve GMP documentation (SOPs, protocols, technical reports, technology transfer protocols, specifications, summary reports to support GMP production, change controls, etc.)

• Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met

• Develop and maintain Quality Agreements with contract manufacturers, suppliers, and laboratories

• Review and approve validation protocols and reports to ensure compliance

• Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans

• Support disposition of DNA plasmid materials

• Review stability protocols and reports

• Collaborate with Manufacturing and lead investigation teams to resolve equipment and process related deviations

• Communicate project requirements and issues to Quality Management

• Conduct internal audits, track progress, and trend results

• Participate in supplier audits

• Support the collection of data/metrics for Management Review

• Support Contract Manufacturing sites and perform Person-in-Plant duties as required

• Review relevant sections of regulatory filings

• Provide guidance on GMP manufacturing from Phase I to Commercial

Here’s What You’ll Bring to the Table:

• BS with at least 3 years’ experience, or a Master’s level degree and 1-2 years’ experience in the pharmaceutical/biotech industry within Quality Assurance or Quality (Assurance) exposure

• Working knowledge of relevant FDA, EU, ICH guidelines and regulations.

• Experience working with CMOs, vendors, and relationship management preferred.

• Experience working with DNA plasmid materials manufacturing preferred.

• Excellent judgment and ability to communicate complex issues in an understandable way.

• Outstanding communication skills (verbal and written).

• Auditing experience is a plus.

• Familiarity with PDA Technical Reports 22, 26, 60, and 79 preferred.

• Knowledge of late-stage pharmaceutical development and validation principles preferred

• Ability to manage multiple projects in a fast-paced environment.

• Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.

Apply here