Quality Specialist III

• Execute activities in support of global clinical trials, such as the Product Specification File.
• Negotiation and maintenance of Quality Agreements
• Supporting audits, ensuring audit responsiveness and CAPA implementation.
• Ensure project milestones as well as expectations such as on time closure are met.
• Monitoring cGMP compliance, identifying and mitigating quality risks
• Ensure cGMP compliance and execute activities in support of disposition of clinical API and Drug Product manufactured at CDMOs, including but not limited to:
• Oversee and execute all required quality activities during the lifecycle of a CDMO/CRO, including but not limited to:
• Leading and approving complex investigations
• Provide quality and GMP compliance oversight of CDMO/CRO operations for the delivery of products to clinical trials, including bulk drug substance (API) and bulk drug product for multiple technical platforms.
• Assessing and approving changes

Note: This is a W2 only role — C2C, C2H will not be considered

BEPC is actively looking for Quality Specialist III in South San Francisco, CA area!

• B.A. or B.S. degree in life sciences.
• Must have experience making GMP release/disposition decisions and associated approval of master process and testing documentation, batch record review, resolution and quality approval of investigations, assessment of changes for clinical API and/or Drug Product, preferably synthetic molecules.
• Minimum of 2 years’ experience in a GMP Quality Assurance role.
• Approval of master process and testing documentation
• Sound knowledge of cGMP, ISO standards, and international regulations for pharmaceuticals.
• Excellent verbal and written communication skills. Fluency in oral and written English is a must.
• Experience with CDMO desired.
• Strong problem-solving skills using critical thinking, identifying risk-based resolutions.
• Minimum of 6 years’ experience in the pharmaceutical industry.
• Ability to interpret quality standards as they relate to CDMO/CRO, especially application of phase appropriate cGMP during product development for a variety of platforms, such as large molecule, synthetic molecule, conjugates, and oligonucleotides.
• Strong interpersonal skills, diplomacy, and negotiation skills to influence and accomplish business objectives.
• Experience with SAP and Veeva is a plus.
• Demonstrated ability to apply cGMP concepts and requirements to evaluate batch disposition using sound judgment and decision making.

BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.

Pay Rate: $48.79 - $58.79 /hour - Determined based on experience

Benefits include medical, dental, vision, and life insurance

Work Model: Hybrid - three days on site, two days remote