GMP Quality Specialist - 36661 at Freyr

Position details:

• Job ID: 36661
• Duration: 12 months
• Shift: Rotating shift: 6:30 AM – 3:30 PM and 1:30 PM – 10:30 PM
• Benefits: Paid sick day, 401k, Discounted health insurance

Qualifications:

• Education Minimum Requirement:
• Bachelor’s degree in Science, Health Science, Engineering, or related discipline (1–3 years of industry experience)
• Required Experience and Skills:
• Previous experience in the pharmaceutical industry
• Demonstrated ability to meet deadlines and drive results
• Strong communication and collaboration skills
• Accountability and a strong problem-solving mindset
• Preferred Experience and Skills:
• Aseptic operations or sterile product exposure
• Quality Assurance/Engineering or other technical role experience
• Experience in a regulated environment (food or pharmaceutical), regulatory/inspection role
• Project management, process data analysis, Lean Six Sigma certification
• Familiarity with SAP, MEDS, or similar systems
• Additional: Beta Lactam screening required

Responsibilities:

• Support manufacturing operations, maintaining familiarity with site processes, procedures, and cGMP guidelines
• Review and approve qualification activities, change controls, batch records, auxiliary forms, investigations, and procedures
• Provide auditing and oversight within aseptic environments (Grades A/B/C), including Grade A/B gowning certification
• Perform quarantine functions and accountability reviews
• Engage in special projects as assigned
• Collaborate with various stakeholders to resolve quality and production needs
• Author, review, and approve documents such as methods, procedures, or protocols
• Track and report metrics as needed; assist with regulatory inspections

Comments/Special Instructions:

• This role supports aseptic operations on a rotating shift
• Must follow site safety requirements and cGMP standards
• Off-shift or weekend coverage may be required based on business needs

Regards,
Vinay Shastri
Senior Associate – Pharmaceutical Recruitment
Phone: +1 609 681 2410
Email: vinay.shastri@freyrsolutions.com
150 College Road West, Ste 102, Princeton NJ - 08540
www.freyrsolutions.com