Aseptic Manufacturing Quality Specialist

Job Title:

Aseptic Manufacturing Quality Specialist (1st Shift and 2nd Shift Openings) Job Description The Quality Specialist provides on-floor quality oversight for cGMP pharmaceutical manufacturing operations, with a focus on aseptic processing and packaging. This role ensures that production and warehouse activities comply with cGMP standards, site SOPs, and applicable regulatory guidelines while supporting real-time quality decisions, exception management, and documentation review. The position is highly hands-on, working closely with operations teams to maintain product quality, data integrity, and a strong culture of safety and compliance. Responsibilities Provide on-floor quality oversight across cGMP manufacturing operations, including formulation, filling, sterilization, packaging, and warehouse activities. Monitor production and warehouse operations to ensure compliance with site SOPs, cGMP requirements, and applicable regulatory guidelines. Support required QA inspections, including sample inspections and defect detection activities. Serve as the primary daily QA support for production and warehouse areas, including packaging line clearance verification, material segregation and containment, low product fill response, rework reconciliations and accountabilities, and real-time documentation review. Respond to exceptions within operations and packaging areas as primary QA event response personnel, including initial impact assessment, product containment, bracketing, scope identification, and direction of immediate actions prior to resuming processing. Assist operations and packaging personnel in generating area-related exceptions and ensure proper documentation and follow-through. Support minor exceptions and phase II manufacturing investigations by gathering data, documenting findings, and contributing to root cause analysis and corrective actions. Attend daily operations staff communication meetings to stay aligned with production plans, quality priorities, and emerging issues. Participate as a team member in Facilities meetings related to Preventive Maintenance, Calibration, and Work Order status and scheduling for operations areas. Assist in punch list generation and verification, as well as conducting area inspections before and after maintenance or project activities. Perform weekly walkthroughs of operations and packaging areas, documenting and communicating observations and potential issues to area management. Support batch release functions as needed by reviewing documentation and verifying compliance with quality standards and data integrity requirements. Accurately complete all quality-related documentation, including batch records, logbooks, deviation reports, and other records, in compliance with cGMP and data integrity expectations. Promptly report any contamination events or deviations from aseptic practices and assist in their investigation and resolution. Promote a strong culture of safety, quality, and compliance within production and warehouse areas through daily interactions and example. Essential Skills Thorough understanding of cGMP principles and applicable regulatory guidelines for aseptic processing, including FDA, EMA, and related standards. 3-6 years of experience in pharmaceutical manufacturing, quality assurance, or aseptic operations. Hands-on experience providing QA oversight on the manufacturing floor in formulation, filling, sterilization, packaging, or warehouse GMP operations. Prior experience performing or verifying line clearances, room clearances, and batch record review. Familiarity with deviation management, root cause analysis, and execution of corrective and preventive actions (CAPA). Proficiency with computers and MS Office software for documentation, analysis, and communication. Bachelor's degree in Life Sciences, Engineering, or a related technical discipline such as Biology, Chemistry, Microbiology, or Pharmaceutical Sciences. Ability to pass a visual acuity exam for production activities and quality product identification. Ability to read and understand military time for scheduling and documentation purposes. Excellent reading comprehension and attention to detail for interpreting batch records and SOPs. Strong attention to detail and situational awareness while working in fast-paced, regulated environments. Basic understanding of sterilization processes, material flows, and controlled environment requirements. Commitment to safety, quality culture, and maintaining high standards of compliance. Ability to demonstrate initiative and sound decision-making while working effectively both independently and as part of a team. Additional Skills & Qualifications Experience observing and evaluating aseptic behaviors, including gowning qualification, environmental controls, and contamination control practices. Experience working in ISO, FDA, or EU Annex 1 regulated environments. Experience with pharmaceutical CAPA systems such as TrackWise, MetricStream, or similar platforms. ASQ inspection certification or similar quality-related certification. Strong communication skills to collaborate effectively with production, warehouse, facilities, and quality teams. Ability to contribute constructively to investigations and continuous improvement initiatives. Work Environment This role is based in a controlled pharmaceutical production environment with a strong focus on aseptic processing and cGMP compliance. The position operates primarily on first shift but requires flexibility to support off-shift or weekend operations as needed based on production schedules. The work is fast-paced and involves frequent presence on the manufacturing floor, including formulation, filling, sterilization, packaging, and warehouse areas. The role requires standing for extended periods while performing on-floor oversight and conducting walkthroughs and inspections. The position also requires the physical ability to lift a minimum of 50 pounds as needed in support of operations. Team members must be able to wear full cleanroom gowning and appropriate Personal Protective Equipment (PPE) in classified and controlled environments. The culture emphasizes safety, quality, collaboration, and adherence to regulatory and data integrity standards. We have openings on 1st shift (5am-3pm) and 2nd shift (3pm-1am). A typical week will be 4, 10-hour shifts. Job Type & Location This is a Contract to Hire position based out of Raleigh, NC. Pay and Benefits The pay range for this position is $33.00 - $37.00/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 Raleigh,NC.

Application Deadline This position is anticipated to close on May 7, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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 Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.