QA Associate - Packaging & Labeling Release (Durham)

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 per year

Disability & Life Insurance

401k company contribution

Professional development

Job summary

Almac Group in Durham, NC is seeking a Quality Assurance Associate to review packaging and labeling batch records and release clinical supplies. The role ensures no product is released unless it meets quality standards per cGMP and Almac SOPs, with responsibilities spanning documentation review, issue escalation, and QA support across sites.

The position follows a Mon-Fri 7:30am-4pm schedule and involves collaboration with multiple teams to maintain compliance and timely product releases for

Qualifications

• 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.
• Release of clinical supplies upon successful review.
• Provide distribution instructions for shipping clinical supplies.
• Provide labeling instructions for Depots.
• Release of clinical supplies upon successful review and activation for countries to allow shipping.
• Assist quality management with escalation of breaches and investigation support.
• Interface with Almac Clinical Services personnel to resolve issues.

Skills

QA knowledge

GMP awareness

Documentation review

Root cause analysis

Education

HS Diploma

Associates Degree

Bachelors 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. The role ensures no product is released unless it meets quality standards per cGMP and Almac SOPs, with responsibilities spanning documentation review, issue escalation, and QA support across sites.

The position follows a Mon-Fri 7:30am-4pm schedule and involves collaboration with multiple teams to maintain compliance and timely product releases for