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Quality Specialist

  • Norwood, MA, United States

$46 to $48 USD / hour

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Job details

Pay
$46 to $48 USD / hour
Experience
3-5 years of experience in a GMP-regulated pharmaceutical, biotechnology, medical device, or related industry environment.
Posting language
English
Posted

Original job description

Quality Assurance Specialist (QA Floor Support) Location: Norwood, MASchedule: Full-Time - 6 Month Contract to beginOur client, a growing biotechnology organization, is seeking a Quality Assurance Specialist to provide Quality On-the-Floor support for GMP manufacturing operations. This individual will play a critical role in ensuring manufacturing activities are performed in compliance with regulatory requirements, internal procedures, and quality standards.The ideal candidate will have experience supporting manufacturing in a GMP-regulated environment and be comfortable making risk-based quality decisions while partnering closely with cross-functional teams.

Key Responsibilities

  • Provide Quality On-the-Floor (QOTF) support for manufacturing operations, including documentation review, line clearance activities, and changeover support.
  • Partner with manufacturing teams to resolve quality-related issues in real time while maintaining compliance with GMP requirements.
  • Make independent, risk-based quality decisions and escalate concerns when appropriate.
  • Identify, assess, document, and communicate quality and compliance risks.
  • Review and approve facility alarms, work orders, equipment records, and return-to-service documentation.
  • Support and review deviations, investigations, CAPAs, change controls, and effectiveness checks.
  • Ensure quality records are complete, accurate, scientifically sound, and compliant with established procedures.
  • Review manufacturing documentation for accuracy, completeness, traceability, and adherence to Good Documentation Practices (GDP).
  • Collaborate with Manufacturing, Facilities, Engineering, Validation, QC, Supply Chain, and other cross-functional teams to support operational success.
  • Promote a culture of quality, compliance, and continuous improvement.

Qualifications

  • Bachelor's degree in Biology, Chemistry, Biochemistry, Chemical Engineering, Biomedical Engineering, Bioengineering, or a related scientific discipline.
  • 3-5 years of experience in a GMP-regulated pharmaceutical, biotechnology, medical device, or related industry environment.
  • Previous experience within Quality Assurance, Manufacturing Quality, or Quality Operations preferred.
  • Working knowledge of GMP regulations, quality systems, deviations, investigations, CAPA management, change control, and data integrity requirements.
  • Familiarity with Good Documentation Practices (GDP) and regulatory compliance standards.
  • Strong problem-solving, organizational, and communication skills.
  • Ability to work effectively in a fast-paced manufacturing environment and collaborate across multiple departments.
  • Strong attention to detail and ability to make sound quality decisions.

If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com Job Type & LocationThis is a Contract position based out of Norwood, MA. Pay and BenefitsThe pay range for this position is $46.00 - $48.00/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 & LocationThis is a Contract position based out of Norwood, MA. Application DeadlineThis position is anticipated to close on Nov 27, 2026. Workplace TypeThis is a fully onsite position in Norwood,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.

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