Quality Assurance Specialist Position Available In Middlesex, Massachusetts

Quality Assurance Specialist Redbock- an NES Fircroft company

Bedford, MA Job Details Contract Estimated:

$98.8K – $122K a year 8 hours ago Benefits Health insurance Dental insurance 401(k) Vision insurance Life insurance Qualifications Biotechnology CGMP Bachelor of Science Quality management GMP 8 years Project management Bachelor’s degree Continuous improvement EMR systems Meeting facilitation Quality systems Senior level Leadership FDA regulations

Full Job Description :

On-site in Bedford, MA. 6 months (through end of 2025)

Summary:

QA QC Support will partner with team members across Quality Assurance, Quality Control, and Technical Operations to ensure effective, efficient, and compliant operations exist at our GxP sites in the Boston area.

Duties/Responsibilities:

• Responsible for oversight of facilities monitoring programs and data related to the Gene Therapy Manufacturing Facility.
• Ensure all data generated in support of the manufacturing operations and facility are appropriately generated, interpreted, and reported.
• Ensure raw materials sampling and testing programs are operating in an appropriate state for the product lifecycle stage.
• Facilitate resolution of facility excursions by leading the cross-functional review committee.
• Ensure oversight, maintenance, and approval of quality records for change control, deviation, CAPA, supplier quality management, documentation, training, and quality review.

Qualifications/Requirements:

• Minimum B.S. degree in an applicable discipline.
• 8-10 years of experience in biopharmaceutical or biotechnology based GMP clinical or commercial operations, within the Quality function.
• Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections.
• Experience with quality systems operations and supplier quality management.
• Experience in facilitation and leading continuous improvement efforts.
• Project management and meeting facilitation skills

Job Type:

Contract Expected hours: 40 per week

Benefits:

401(k) Dental insurance Health insurance Life insurance Vision insurance

Schedule:

8 hour shift

Education:

Bachelor’s (Preferred)

Experience:

GMP clinical or commercial operations: 8 years (Preferred) biopharma or biotech industry: 8 years (Preferred) quality systems operations: 8 years (Preferred) supplier quality management: 8 years (Preferred) Ability to

Commute:

Bedford, MA 01730 (Preferred)

Work Location:

In person