GMP Quality Assurance Specialist

Job Description

Job Description

Job Title: Quality Assurance Specialist

Job Description

The Quality Assurance Specialist will provide essential support to Quality Operations, with a primary focus on material and batch release activities within a fast-paced pharmaceutical environment. The successful candidate will leverage strong documentation, organizational, and communication skills to ensure compliance with Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGxP) regulations. This role requires a detail-oriented individual with the ability to assess and maintain the quality of materials, products, and processes.

Responsibilities

• Maintain accurate and consistent tracking, data entry, and follow-up within departmental GMP databases.
• Review completed manufacturing, filling, labeling records, and analytical data to ensure conformance with applicable regulations, SOPs, specifications, and acceptance criteria.
• Regularly review and update GMP system procedures to ensure alignment with current regulatory standards and company policies.
• Perform hands-on monitoring of production and non-production activities, identifying and reporting any observed non-compliance to Quality Management.
• Ensure finished products conform to both government and company standards while meeting cGxP regulations.
• Prepare and conduct initial reviews of documentation for the release of acceptable product lots and vendor materials.
• Assist in investigating deviations, identifying root causes, and proposing corrective actions.
• Review and provide input on SOPs, change control documents, and protocols related to cGxP programs as assigned by management.
• Report key quality metrics and performance indicators as required.
• Participate in internal and external audits, including customer and regulatory audits, as directed by Quality Management.

Essential Skills

• Proficiency in GMP, inspection, batch record review, and document control.
• Experience in CAPA, audit preparation, and investigation and analysis.
• Strong quality assurance experience in a pharmaceutical setting.

Additional Skills & Qualifications

• Associate's Degree with 4 years of relevant experience or Bachelor's Degree with 2 years of relevant experience.
• Working knowledge of deviation management and CAPA resolution.
• Familiarity with FDA, EU, and ISO regulatory frameworks is preferred.

Work Environment

The position involves working in both a lab and office setting. The lab environment includes cleanrooms classified as level 10k and 100k, requiring sterile gowning and maintaining certification for sterile gowning.

Job Type & Location

This is a Contract to Hire position based out of WINSTON SALEM, North Carolina.

Job Type & Location

This is a Contract to Hire position based out of WINSTON SALEM, NC.

Pay and Benefits

The pay range for this position is $30.00 - $33.00/hr.

Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in WINSTON SALEM,NC.

Application Deadline

This position is anticipated to close on Nov 14, 2025.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] for other accommodation options.