Quality Specialist (Document Reviewer/Change/Capa)

Hybrid

Position Title: Quality Specialist

Job Description:

Quality Specialist – document reviewer and change management record owner 1-2 staff in this area with 5 years of experience in document ownership, review and revision as well as change management that goes along with that role.

Education:

• Bachelor’s degree in Science or Engineering

Top 3-5 skills:

• familiar with US FDA CFRs, regulatory guidance, and cGMPs;
• Prior experience in an audit, compliance or investigation/CAPA role;
• Experience with the following qualitysystems: risk management, change management; prior experience in a quality assurance role in a biologics manufacturing operation, or similar; could also have prior role in training/learning & performance within Quality; problem-solving techniques for root cause analysis in investigations.

Job Type: Contract

Salary: $45.00 - $47.00 per hour

Experience level:

• 5 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person

Experience:

• Documentation review: 5 years (Preferred)
• change control: 5 years (Preferred)
• capa: 5 years (Preferred)
• US FDA CFRs, regulatory guidance, and cGMPs;: 5 years (Preferred)
• Quality assurance background: 5 years (Preferred)
• pharma or medical device industry: 5 years (Preferred)

Ability to Commute:

• Worcester, MA 01602 (Preferred)

Work Location: In person