Quality Assurance Specialist

Job Title: Quality Assurance Specialist I

Job Description

The Quality Assurance Specialist I ensures that manufacturing operations and quality systems comply with Standard Operating Procedures (SOPs), regulatory requirements (FDA, EU, ICH), and industry standards at a GMP manufacturing site. This role provides on-the-floor Quality Assurance oversight, reviews critical GMP documentation, and supports key quality system activities such as investigations, deviations, CAPAs, and change controls. The position actively contributes to maintaining and continuously improving the sites quality management system and quality culture through consistent application of quality processes and procedures.

Responsibilities

• Perform on-the-floor Quality Assurance oversight of GMP manufacturing operations to ensure compliance with approved procedures and quality standards.
• Review executed batch records and GMP documentation for accuracy, completeness, and adherence to regulatory and internal requirements.
• Support investigations, deviations, CAPAs, and change controls under the guidance of sr. Quality Assurance staff.
• Identify, document, and escalate quality events, compliance risks, and atypical observations in a timely and appropriate manner.
• Partner closely with Manufacturing, Quality Control, and other support functions to ensure consistent adherence to approved procedures and quality expectations.
• Support internal audits, client audits, and inspection readiness activities by providing documentation, explanations, and on-the-floor support as needed.
• Maintain current knowledge of applicable GMP regulations, site procedures, and quality systems, and apply this knowledge in daily activities.
• Support CAPA systems, change controls, risk management activities, and general quality oversight to drive continuous improvement.
• Review GMP documentation with strong attention to detail, ensuring data integrity and traceability.
• Contribute to the maintenance and continuous improvement of the sites quality management system and quality culture through consistent use of quality processes and procedures.
• Use electronic quality systems and standard office applications to document, track, and report quality activities and issues.
• Support operations during non-standard hours when business needs require, helping to ensure uninterrupted quality oversight.

Essential Skills

• Minimum 1+ years of GMP industry-related experience with a Bachelors Degree in Life Sciences, Chemical Engineering, Biochemical Engineering, or a related discipline.
• Working knowledge of FDA, EMA, and applicable GMP regulations and guidelines.
• Understanding of GMP manufacturing operations and quality systems within a regulated environment.
• Hands-on experience with CAPA systems, change controls, and quality oversight activities.
• Ability to review GMP documentation, including batch records, with strong attention to detail and accuracy.
• Basic knowledge of deviations, CAPAs, investigations, and change control processes.
• Strong written and verbal communication skills suitable for a regulated, documentation-heavy environment.
• Effective organizational, time management, and problem-solving abilities to manage multiple priorities.
• Proficiency with electronic quality systems and Microsoft Office applications (such as Word, Excel, and Outlook).
• Ability to identify, assess, and appropriately escalate compliance concerns and quality risks.

Additional Skills & Qualifications

• Bachelors degree preferably in technology, engineering, microbiology, life sciences, or a related field; equivalent combinations of education, training, and relevant work experience are accepted.
• Familiarity with ICH guidelines and EU regulatory expectations for GMP environments.
• Experience supporting internal or client audits and regulatory inspection readiness activities.
• Comfort working cross-functionally with Manufacturing, Quality Control, and other support teams in a fast-paced environment.

Work Environment

This is a day-shift role on a 12-hour rotating schedule. The schedule follows a two-week rotation: Week 1 consists of Monday, Tuesday, Friday, and Saturday; Week 2 consists of Sunday, Wednesday, and Thursday. Standard shift hours are approximately 6:45 a.m. to 7:15 p.m., including a 30-minute lunch period. The position requires routine presence in GMP manufacturing and controlled cleanroom environments, with strict adherence to gowning requirements and the use of appropriate personal protective equipment (PPE) in accordance with site procedures. Work involves frequent standing and walking on the manufacturing floor, as well as computer-based tasks for documentation and quality system activities. The role requires the ability to gown and work in classified manufacturing areas, occasionally lift up to 25 pounds, and maintain sufficient visual acuity to review documentation and perform quality inspections. The environment is highly regulated and process-driven, with a strong focus on quality culture, collaboration, and continuous improvement, and may require support during non-standard hours based on business needs.

Job Type & Location

This is a Contract position based out of Plainville, MA.

Pay and Benefits

The pay range for this position is $28.00 - $30.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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)

Job Type & Location

This is a Contract position based out of Plainville, MA.

Application Deadline

This position is anticipated to close on Nov 16, 2026.

Workplace Type

This is a fully onsite position in Plainville,MA.

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.