Analyst III QA
Gaithersburg, MD Posted: 9/22/2021
Our client, a global biopharmaceutical company, is seeking a quality assurance analyst III to support their quality assurance team at their fantastic facility in the Greater Baltimore area. The quality assurance analyst III will be tasked with supporting preparation, testing, and monitoring of compliance to established quality assurance processes and standards for manufacturing and production.
- Review and approve SOPs, summary reports, manufacturing records, quality control laboratory data for batch and material releases, deviation investigations, CAPAs, change controls, and validation protocols.
- Interact with suppliers and address nonconformities through investigations. Evaluate corrective and preventative actions to avoid recurrence.
- Coordinate, schedule, and conduct internal and external quality system audits. Review prior internal audits and regulatory inspections, reviewing procedures, processes, and activities in creating the audit plans.
- Review and perform disposition of raw materials, components, bulk drug substance, and final drug substance.
- Collaborate with contract manufacturers responsible for filling, inspection, labeling, and packaging of product by providing quality oversight for change controls, deviations and other quality systems that may impact products.
- Provide supplier quality oversight. Perform supplier change notification impact assessment and ensure implementation.
- Lead or participate in inspection readiness plans and activities and serve as subject matter expert in quality systems.
- Conduct regulatory surveillance to maintain current regulatory expectations and devise and provide GXP training to the facility.
- Maintain quality systems including, but not limited to, deviations, CAPAs, change control, and management review in support of manufacturing operations.
- Lead or participate in cross-functional teams to address facility issues using methodical problem-solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact to product.
- Serve as technical expert to assist and provide support to end users.
- Bachelors Degree in Scientific or related fields
- A minimum of five 5 years of cGMP Quality experience
- Strong Commercial manufacturing experience (Large Molecules)
- Quality Auditor, Six Sigma, or equivalent certification/education preferred
- Prior experience with US, EU and Canadian pharmaceutical regulations, ISO standards
- Knowledge and application of GMP principles, and working in an FDA regulated environment
- Strong communication skills: oral/written and listening
- Strong facilitation skills
- Experienced in developing and delivering technical/classroom training
- Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability
- Interpersonal skills: team building, consensus building, conflict resolution
- Critical analytical skills, strong verbal and communication skills
- Ability to work under pressure and analyze processes within scheduled timeframes
- Ability to work independently in conducting quality system and process audits.
- Excellent presentation skills, including written and verbal communication skills
- Ability to travel (10%)
Established in 1995, PTS Advance provides people and tools to companies that want to do more than just "fill a position". Our expertise includes attracting and retaining key talent, while managing assignments in a safe, compliant, and transparent manner. We are honest and transparent in the process because we put you first.
Interested? Contact Christopher Mercedes at 949-268-4087 or via email at Christopher.Mercedes@PTSadvance.com for a confidential discussion.
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