QA Associate - GMP Compliance & Clinical Supplies Release

ALMAC Group; Durham (NC); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Medical, Vision & Dental

20 days PTO per year

12 holidays

Disability & Life Insurance

401k

Professional development programs

Job summary

Almac Group in Durham, NC is seeking a Quality Assurance Associate to review packaging and labeling batch records and release clinical supplies. This role ensures products are manufactured, packed, and held in compliance with cGMP and client specs.

The position requires documenting and approving packaging materials, executing labeling records, and coordinating releases with global sites. It also involves reporting GMP breaches, supporting investigations, and collaborating across QA teams.

Qualifications

• HS Diploma or equivalent.
• 4+ years Pharmaceutical Experience (with HS Diploma).
• 2+ years Pharmaceutical Experience (with Associates Degree).
• 1+ years Pharmaceutical Experience (with Bachelors Degree).
• Knowledge of Current Good Manufacturing Practices (cGMP).
• Completing GMP document auditing/reviewing.
• Working with Quality Systems.

Responsibilities

• Review and approve documentation from any site associated with packaging and labeling of clinical supplies, including but not limited to: Packaging Specifications; Packaging and Labeling methods and design layout; Executed packaging and labeling records; Medication number lists.
• Release of clinical supplies upon successful review.
• Distribution instructions shipping clinical supplies.
• Labeling Instructions for Depots.
• Release of clinical supplies upon successful review and activation of specific countries to allow shipping activities to commence.
• Assist quality management with the following tasks as needed: Report/escalate serious/potentially serious breaches of GMP compliance or matters of concern to QA Team Leader in an open and timely manner for appropriate resolution.
• Provide support to the Lead Investigators during the conduct of an investigation to enable them to perform a thorough root cause investigation
• Interface with all levels of Almac Clinical Services personnel in resolving issues by providing QA support.
• Notify Client Services of any issues which may impact the customer (i.e. quality issues, batch record completion deadlines).

Skills

HS Diploma

Pharma Experience 4+ yrs

Pharma Experience 2+ yrs with AA

Pharma Experience 1+ yrs with BA

cGMP knowledge

GMP document auditing

Quality Systems

Education

Bachelor's degree

Job description

Almac Group in Durham, NC is seeking a Quality Assurance Associate to review packaging and labeling batch records and release clinical supplies. This role ensures products are manufactured, packed, and held in compliance with cGMP and client specs.

The position requires documenting and approving packaging materials, executing labeling records, and coordinating releases with global sites. It also involves reporting GMP breaches, supporting investigations, and collaborating across QA teams.