Quality Assurance Specialist

About the role

The Specialist, Quality ensures compliance with quality system's procedures and assesses regulatory and quality risks in activities and processes according to regulatory agency guidelines and company practices. This unique role is accountable for routine Quality Assurance responsibilities related to the production and disposition of products manufactured and tested on-site.

Responsibilities

• Support technical operations functions (i.e. Manufacturing, Facilities & Engineering, Supply Chain, Quality Control, Analytical Development, Product Development/Manufacturing Sciences & Technology) to assure compliance to the quality manual and maintain collaborative quality relationships.
• Lead deviations and laboratory investigations related to GMP manufacturing and analytical testing, respectively, with cross-functional owners.
• Determine corrective/preventative actions (CAPA) and Verification of Effectiveness (VoE) and drive on-time implementation and closure.
• Work with appropriate partners to manage change controls in a phase-appropriate manner for clinical stage products that supports quality risk management (i.e. New Product Introduction, New Facility, & Manufacturing Process Change Controls).
• Provide ILT trainings for annual GMP/GDP, Quality Manual, Quality Risk Management, Deviation/CAPA, Change Control.
• Work with QA doc control to ensure accurate issuance of batch record documentation (i.e. lot/media batch records and in-process/QC/final product labels) to manufacturing.
• Review routine manufacturing batch documentation and quality control data for in-process and finished product to support disposition and lot closure.
• Perform approval of equipment alarm acknowledgements, equipment activation and PM/Calibration schedules in computerized asset and alarm management system(s).
• Review routine material release documentation for quality release of raw materials used for manufacturing and quality control testing.

Qualifications

• MA/MS in Biology, Chemistry, Microbiology, Engineering, or a related field is required; OR
• BA/BS with 2+ years; OR
• Associate's degree with 4+ years; OR
• High School diploma with 5+ years of Quality Assurance or GMP experience.
• 2-4 years of Cell Therapy Experience
• Knowledge of and ability to apply GMP in conformance to US standards.
• Proficient in cGMP regulations, quality systems and regulatory requirements.
• Experience writing, evaluating and closing investigations, CAPAs and change control records.
• Adapt best practices for stage appropriate products.
• Manufacturing QA experience supporting batch review and product disposition.
• Candidates who have managed deviations from the Quality Assurance perspective, including reviewing deviations through closure and ensuring GMP compliance.
• 2-3 years of directly relevant QA experience who can contribute with minimal training.
• Strong GMP knowledge.
• Must have a QA background and QA operations experience.
• Hands-on experience with: Batch record review, Preparing batches for disposition, Deviation management, Change controls, Batch disposition, Deviations (QA reviewer perspective), Good Documentation Practices (GDP).

Skills

None specified in the job posting.

Benefits

• Healthcare Insurance
• Dental Insurance
• Vision Insurance
• 401(k) Plan

Pay

N/A

Schedule

Working Days/Hours: 9am-5pm Sunday-Thursday OR Monday-Friday (possible weekend work)