Quality Assurance Specialist

Job Title: Quality Assurance Specialist - 3rd ShiftJob Description

The Quality Assurance Specialist - 3rd Shift provides day-to-day technical, quality, and operational support to pharmaceutical manufacturing operations. This role ensures that production activities comply with cGMP standards, regulatory expectations, and safety requirements while supporting efficient, high-quality output in a fast-paced, highly regulated environment.

Responsibilities

• Provide floor-level technical support to manufacturing operators and supervisors during 3rd shift operations.
• Troubleshoot equipment issues, process deviations, and workflow bottlenecks to maintain consistent production performance.
• Monitor production activities and assist with implementing corrective and preventive actions to address quality and operational concerns.
• Prepare, revise, and maintain GMP documentation, including standard operating procedures (SOPs), batch records, and logbooks.
• Ensure adherence to FDA and other global regulatory requirements across all manufacturing processes.
• Support investigations, develop CAPAs, and participate in change control processes to drive continuous improvement and compliance.
• Perform data collection, review, and analysis to verify compliance with cGMP and to identify opportunities for process optimization.
• Partner with Process Control teams to support equipment qualification and validation activities.
• Assist with process improvements, optimization initiatives, and technology transfers within manufacturing operations.
• Support coordination of preventive and corrective maintenance activities with Engineering and Maintenance departments.
• Train manufacturing personnel on procedures, new equipment, and process changes to promote consistent and compliant operations.
• Act as a subject matter liaison between Production, Quality, and Maintenance teams to ensure alignment on quality and operational standards.
• Uphold and promote a strong culture of safety and compliance on the production floor and within controlled environments.
• Support environmental monitoring and compliance activities as needed to maintain cleanroom and controlled area standards.
• Perform quality checks, inspections, and audit-related activities to verify product and process conformance to established specifications.

Essential Skills

• 1-3+ years of experience in pharmaceutical, biotech, or other regulated manufacturing environments.
• Working knowledge of cGMP, GDP, and applicable regulatory guidelines.
• Strong analytical and problem-solving skills for technical troubleshooting and issue resolution.
• Excellent communication skills for clear interaction with cross-functional teams and documentation of activities.
• Strong documentation skills for accurate completion and maintenance of GMP records and reports.
• Ability to work effectively in a fast-paced, highly regulated manufacturing environment.
• Demonstrated attention to detail and accuracy in all quality-related tasks.
• Technical troubleshooting capabilities for equipment, process, and workflow issues.
• Collaboration and cross-functional communication skills to work effectively with Production, Quality, Engineering, and Maintenance.
• Effective time management and prioritization skills to handle multiple tasks and shifting priorities.
• Continuous improvement mindset focused on enhancing quality, efficiency, and compliance.
• Strong compliance and quality focus, with commitment to regulatory and safety standards.
• Experience with quality assurance, quality control, quality checks, inspection, and environmental monitoring.

Additional Skills & Qualifications

• Experience in sterile or aseptic operations and biologics manufacturing is preferred.
• Knowledge of Six Sigma or other continuous improvement methodologies is an advantage.
• Familiarity with batch records, inventory management systems, and laboratory information management systems (LIMS) is beneficial.
• Experience supporting audits and participating in quality-related inspections.
• Ability to train and coach manufacturing personnel on procedures and process changes.
• Comfort working in cleanrooms and controlled environments with strict compliance requirements.

Work Environment

This role is primarily on-site in pharmaceutical manufacturing areas, including cleanrooms and controlled environments that require appropriate gowning in classified areas. The position supports 3rd shift operations and works within a highly regulated, safety-focused setting that emphasizes compliance with cGMP and regulatory standards. Typical production schedules follow extended shifts, with standard hours for 1st shift noted as 6:00 AM to 4:30 PM over four 10-hour days, and availability may be required on various days of the week and for a 5-day schedule as indicated. The work involves close collaboration with Production, Quality, Engineering, Maintenance, and Process Control teams, frequent interaction with manufacturing equipment and monitoring systems, and adherence to cleanroom protocols and documentation requirements.

Job Type & Location

This is a Permanent position based out of Syracuse, NY.

Pay and Benefits

The pay range for this position is $52000.00 - $62400.00/yr.

Benefits: 401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Parental leave Referral program Tuition reimbursement Vision insurance

Workplace Type

This is a fully onsite position in Syracuse,NY.

Application Deadline

This position is anticipated to close on Aug 14, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

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.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.