What are the responsibilities and job description for the Quality Specialist position at BCforward?
Job Details:
- Title: Quality Compliance Specialist
- Location: 556 Morris Avenue, Summit, NJ 07901
- Duration: 12 months (possible extension based on performance)
- Work Schedule: Flexible, with at least 50% onsite as required by the manager
Key Responsibilities:
- Conduct historical performance reviews of equipment, analyze trends, and recommend actions.
- Ensure compliance of the ECQ department with regulatory guidelines and internal policies.
- Lead compliance projects to maintain regulatory adherence.
- Perform gap analyses and implement necessary changes.
- Assist in internal and external audit preparation.
Must-Have Skills & Qualifications:
✔ Bachelor's degree in Engineering or Science (Master's preferred)
✔ 4 years (BS) or 2 years (MS) in a GMP-regulated industry
✔ Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, and 21 CFR Part 11
✔ Experience with pharmaceutical, manufacturing, and laboratory equipment
✔ Strong problem-solving, communication, and organizational skills
Salary : $55 - $58
