Job Title: Quality Assurance Associate

Job Description

We are seeking a dedicated and experienced Quality Assurance Associate to join our team in North Carolina. This is a fully onsite position, working Monday through Friday with a flexible daytime shift schedule. The role involves working directly with plant manufacturing and support groups for ongoing bulk drug substance manufacturing and new product introduction, including development, clinical, and commercial operations. This position will facilitate real-time decision-making to ensure adherence to GMP quality requirements and foster a strong partnership between Manufacturing and Quality staff.

Responsibilities

• Provide ongoing Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and other applicable regulations.
• Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP, and cGMP requirements.
• Drive closure/completion, including review and approval of cGMP processes, procedures, documents, and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records, and validations.
• Oversee and provide guidance during on-the-floor analytical testing.
• Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and company requirements relating to GMP, GDP, safety, and other controls.

Essential Skills

• Knowledge of process and facility equipment.
• Ability to interpret and apply Good Manufacturing Practices (GMP).
• Quality assurance or manufacturing experience in the pharmaceutical or medical device industry.
• Written and spoken fluency.
• Strong GMP and GDP knowledge.
• Experience with electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems.
• Experience with deviations and corrective actions.

Additional Skills & Qualifications

• High school diploma/GED with 4 years of work experience, or an Associate degree with 2 years of work experience, or a Bachelor's degree with 6 months of work experience, or a Master's degree.
• Demonstrated ability to work as a team player and independently.
• Strong communication skills and ability to complete assignments and meet timelines.

Work Environment

This role requires you to work onsite in North Carolina, Monday through Friday with a flexible daytime shift schedule. You will be part of a team providing ongoing support to functional teams and 24/7 operations. The work environment includes maintaining facilities and equipment to comply with GMP, GDP, safety, and other regulations. You will be expected to provide quality oversight to ensure products are manufactured, tested, stored, and distributed according to the highest standards.

Pay and Benefits

The pay range for this position is $28.00 - $32.00/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 Holly Springs,NC.

Application Deadline

This position is anticipated to close on Mar 19, 2025.

About Actalent

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $28 - $32