QA Associate

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 is currently seeking a Quality Assurance Associate for our Durham, NC location. The Quality Assurance Associate is primarily concerned with the review of packaging and labeling batch records and the release of clinical supplies. The Quality Assurance Associate assures that no product is released until its quality has been deemed satisfactory having been manufactured, processed, packed, and held in accordance with Almac Clinical Services Standard Operating Procedures, current Good Manufacturing Practices, and customer specifications.

Mon-Fri 7:30am-4pm

Responsibilities include but are not limited to:

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).

Qualifications

Required Experience / Education

• 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

Preferred Experience / Education

• Bachelor's degree

• Previous experience working under an established Quality System or within a Pharmaceutical /GXP environment

• Knowledge of Packaging/Labeling/Storing/Shipping Clinical Supplies
• Familiar with Clinical Trial Process

What can Almac Group offer you?

• Medical, Vision & Dental benefits from the 1st of the month following start date
• 20 days PTO per year, accrued monthly following start date
• 12 holidays per year
• Company paid Long and Short-term disability along with Life Insurance
• 401k company contribution
• Professional development programs/ continuous learning opportunities

Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing 6,600 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. 'Partnering to Advance Human Health' is more than just a tagline - it is our way of life.

Embracing diversity is at the heart of enhancing Almac Group's unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.

Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.

EEO is the Law

EEO is the Law GINA Supplement

Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at [e-mail] to request assistance.