What are the responsibilities and job description for the GMP Quality Specialist - 36661 position at Freyr?
Position details :
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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
