GMP Documentation Specialist II

cosettepharma; Lincolnton (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

cosettepharma in Lincolnton, North Carolina is seeking a qualified professional to facilitate the issuance of critical cGMP documentation to support daily operations. This role requires attention to detail and the ability to maintain compliance with industry standards.

The ideal candidate will have over 5 years of relevant pharmaceutical experience and excellent communication skills, ensuring efficient handling of quality processes. Familiarity with cGMP and FDA requirements is essential.

Qualifications

• 5+ years pharmaceutical experience in a Document Control Environment preferred.
• Ability to work under pressure and manage multiple tasks.
• Good knowledge of quality assurance/control processes.

Responsibilities

• Issue a range of cGMP documentation facility-wide.
• Compile and enter data for Annual Product Quality Reviews (APQRs).
• Review documents for adherence to good documentation practices.

Skills

Excellent communication skills

Computer skills

Good organizational skills

Strong knowledge of cGMP and FDA requirements

Working knowledge of pharmaceutical processing

Education

High School Diploma

Tools

Microsoft Office

Microsoft Outlook

Job description

cosettepharma in Lincolnton, North Carolina is seeking a qualified professional to facilitate the issuance of critical cGMP documentation to support daily operations. This role requires attention to detail and the ability to maintain compliance with industry standards.

The ideal candidate will have over 5 years of relevant pharmaceutical experience and excellent communication skills, ensuring efficient handling of quality processes. Familiarity with cGMP and FDA requirements is essential.