QA Specialist

Responsibilities:

• Perform technical review of cGMP documentation, including change controls and validation documents,
• for completeness and compliance to GMPs as outlined by governmental regulations and internal procedures.
• Ability to work with a cross functional team at a fast-paced environment.
• Provide advice and counsel on cGMP and related quality assurance issues to the value stream.
• Demonstrate sound decision making relating to quality issues.
• Provide on the floor QA support and perform QA Operations activities.
• (batch record review and issuance, room release, line clearance, documentation review etc)
• Take initiative to resolve quality documentation concerns (e.g., investigations, deviations, change controls, and other required documentation).
• Perform review and support regarding discrepancies and/or anomalies noted during QA review of associated processes.
• This includes deviation investigations, customer complaint investigations, etc
• Alert management of production trends which may serve as forewarning of process or equipment problems.
• As necessary, initiate CAPA investigations to address these issues.
• Write and/or revise controlled documents in support of job responsibilities.
• Routinely communicate and report deviations from procedures/processes to Quality Assurance Management and initiate appropriate action as necessary.
• Ensure all GMPs, validation, quality, safety and environmental regulations are met. Adhere to all GSK safety guidelines and procedures.

Education & Experience:

• BS/BA in biology, chemical engineering, life sciences. Degree in other discipline if sufficient technical depth has been achieved from professional experience.
• Job related experience:
• Minimum of 3 years pharmaceutical experience in Quality Assurance preferably in GMP Biologics Secondary Manufacturing, biotech or pharmaceuticals.
• Experience in aseptic Filling and Formulation operations preferable.
• science practices related to the business in order to apply knowledge to daily activities.
• Training and work experience in root cause analysis tools (Isikawa) required.
• Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance.
• Working knowledge of validation principles, aseptic processing, quality systems and FDA regulations.
• The ability to communicate both verbally and in writing with all levels both inside and outside of the organization.
• The ability to clearly write QA documentation as necessitated by regulatory agencies and internal policies.
• Able to prioritize and decide appropriate course of actions and to effectively implement decisions.
• Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions.