QC Specialist

Position can be onsite OR Remote if candidate resides in Seattle, WA

Must be available on weekends...if needed

Required Competencies

• Knowledge of cGMP, ISO, FDA, MHRA, PMDA, USP, PDA, JP, and EP regulations and guidelines as related to the manufacture of cell therapy products.

• Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.

• Strong knowledge of Quality Systems including SOPs, Change Controls, Deviations, CAPAs, and Risk Assessments.

Duties and Responsibilities

• Technical document authoring and documentation of GMP release activities.
• Method development and validation for incoming consumables and raw materials.

• Comprehensive understanding of guidelines and can independently develop, write and execute method, protocols, reports, and other related documents.
• Assist management with investigations and deviations.
• Provide support for specification development, JOS and HA inspection.
• Provide support for team change controls, deviations and CAPAs
• Support new material introductions, changes and qualifications
• Assist in the management of retains
• Coordinate materials across multiple sites:
• Management and scheduling of critical materials across multiple sites.
• Coordinating release and qualification actives for critical reagents across sites.
• Providing documentation support for material release across sites
• Author and revise GMP documents
• Author new documents used in the GMP test execution, including but not limited to material specifications, methods, justification of specifications, SOPs, protocols and reports.
• Revise existing documents as needed.
• Manage the development of documents through the GMP document management systems.
• Work with internal teams to obtain an in-depth understanding of the process and the documentation requirements.
• Produce high-quality documentation that meets applicable standards and is appropriate for its intended audience

Education and Experience

• Bachelor’s Degree required, preferable in Science
• Advanced Degree preferred
• 3-5 years of relevant work experience, preferable in a regulated environment
• An equivalent combination of education and experience may substitute

Job Types: Full-time, Contract

Pay: $16.00 - $29.00 per hour

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Summit, NJ 07901: Reliably commute or planning to relocate before starting work (Preferred)

Education:

• Bachelor's (Preferred)

Experience:

• Quality assurance: 2 years (Preferred)
• CAPA: 2 years (Preferred)
• Deviations: 2 years (Preferred)
• Quality investigations: 2 years (Preferred)

Work Location:

• One location

Work Location: One location