Job description
Azzur Cleanrooms on Demand (COD) is looking for a Sr Quality specialist to perform and verify GMP activities to support cleanroom and raw material program operations at all COD facilities in Waltham, MA.
Essential Functions:
- Processing deviations and CAPA records.
- Environmental monitoring program review and related investigations.
- Review and approve site-specific forms for adherence to approved procedures such as cleanroom cleaning forms, shipping forms, and raw material disposition forms.
- Scan required client documents in a timely manner per approved client quality agreements
- Execute and adhere to internal COD and client Material Management standards and specifications.
- Train new staff and clients on quality processes and procedures.
- Compiling quality-related metrics to support quality management review.
- Support internal/external audits and required responses/CAPA actions.
- Aid in the incorporation of new clients into the facility.
- Potential to travel to other sites to support training and assist local ACoD facilities.
Requirement:
- Bachelor's degree in engineering, science, or equivalent
- 5-7 years experience in a quality role.
- CAPA/change controls experience
- GMP Experience
- Raw Material releasing Experience.
- Environmental monitoring experience
Benefits
Fulltime Employment with Azzur can offer you:
- Flexible PTO
- Training and Development Opportunities
- 401(k) match
- Bonus Eligibility
- Medical Benefits
- Paid Holidays
- Company provided laptop
Who we are:
Azzur CODAs you look to start your journey on the next cure that can heal patients and save lives, lack of space to manufacture and properly follow cGMP processes can be a major hurdle. To address the unique needs of start-ups in your position, Azzur Cleanrooms on DemandTM is here to support production for early-phase partners, helping you accelerate your time to market. Truly unique to the industry, our on-demand cleanrooms as a service include cGMP-compliant cleanroom space, warehousing, and materials management. This allows partners to execute manufacturing activities without the need for facility ownership or reliance on contract manufacturing organizations (CMOs). Unlike working with a CMO, Azzur Cleanrooms on DemandTM mitigates risk, affording you full access and control to your IP, space, and activities. This is all backed by quality management consultants with decades of experience implementing phase-appropriate GMP for industry leaders.
EEO Statement
Azzur Group is an equal-opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
Job Type: Full-time
Pay: $85,000.00 - $95,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible schedule
- Flexible spending account
- Health insurance
- Health savings account
- Paid time off
- Parental leave
- Professional development assistance
- Referral program
- Relocation assistance
- Retirement plan
- Vision insurance
Schedule:
- 8 hour shift
Ability to commute/relocate:
- Waltham, MA 02452: Reliably commute or planning to relocate before starting work (Required)
Experience:
- Quality assurance: 5 years (Preferred)
- CAPA: 2 years (Preferred)
- CGMP: 2 years (Preferred)
- Document review: 2 years (Preferred)
Work Location: In person
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