Quality Assurance Technician II-Quality Systems/Document Control

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

Innovating every day.

Basic Purpose

Issuance of a range of cGMP documentation to support daily processes facility wide.

Essential Functions and Responsibilities

• Assign numbers per Good Documentation Practices in master logs for GMP document issuances.
• Issuance of Master Records, Notebooks, Logbooks, cGMP forms, etc.
• Ability to compile and enter data in support of Annual Product Quality Reviews (APQRs).
• Ability to review executed documents for adherence to good documentation practices and outlined procedures.
• Navigate and maintain documents in the electronic Quality Management System, Veeva Vault.
• Maintenance of the filing system for the retrieval and archiving of GMP documentation.
• Other duties as assigned by manager

Knowledge, Skills, Qualifications and Physical Requirements

The following describes the general knowledge, skills, qualifications and physical requirements normally associated with performing the essential functions of this job. In compliance with law Cosette Laboratories will consider varying or modifying these standards to provide individuals with disabilities an equal employment opportunity.

Education/Training/Work Experience

• High School Diploma
• 5 + years pharmaceutical experience in Document Control Environment (preferred), will consider comparable experience in related field

Specialized Knowledge and Skills

• Excellent communication skills (written and oral)
• Computer skills
• Good organizational skills
• Work well under pressure
• Strong knowledge of cGMP and FDA requirements
• Working knowledge of pharmaceutical processing, quality assurance/control processes and practices

Equipment and Applications

• Training System Software
• Enforcement Solutions
• Microsoft Office
• Microsoft Outlook

Work Environment and Physical Demands (List required PPE's)

• Ability to lift 25 lbs
• No PPE required unless entered manufacturing or lab areas