Job description
Billerica, MA - Pharma
Senior QC Analyst
$90,000 - $120,000 + 10% bonus

Our client is an industry leading pharmaceutical company with headquarters in countries across the globe. They are looking to develop their quality department in Massachusetts and are in need of a Senior QC Analyst

Do you have?

• Minimum of 5-7 years related experience - cGMP/FDA/Life Science
• Strong knowledge of 21 CFR Parts 210, 211 and aseptic drug manufacturing
• Experience in managing and developing training initiatives
• Strong knowledge of trackwise and QMS
• Extensive knowledge of cGMPs, GLPs
• Experience in use of balances, UV/VIS Spectrometer, Conductivity Meter, TOC Meter, pH meter, Autotitrator etc.

...Then this is an excellent opportunity for you!

You will:

• Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing training for employees to effectively use the electronic Quality Systems
• Design, plan, implement, and manage documentation programs, policies, and procedures
• Provide QA review of Annual Product Reviews (APRs)
• Lead Monthly Quality Review Board (QRB) meetings, Quality Investigation Board (QIB)
• Assist with FDA and other compliance audits including corporate audits.
• Participate in investigation team efforts to determine root cause for critical quality events and recommend appropriate CAPA

If this sounds like the position for you, apply below!

Job Type: Full-time

Salary: $90,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee discount
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Vision insurance

Experience level:

• 5 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Ability to commute/relocate:

• Billerica, MA 01821: Reliably commute or planning to relocate before starting work (Required)

Experience:

• CGMP: 5 years (Preferred)
• Wet chemistry: 5 years (Preferred)
• Leading Investigations: 5 years (Preferred)
• FDA regulations: 5 years (Preferred)
• Quality management: 5 years (Preferred)

Work Location: One location

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