Quality Assurance Specialist-raw Amterials

Job Description

Job Description

Job Duties

• Demonstrate general knowledge of standard manufacturing compliance, quality disposition, and quality system review.
• Partner closely with peers for the disposition of Plasmid, Drug Substance, and Drug Product.
• Participate in quality-focused teams across broad ecosystem of functions.
• Author and review SOPs, policies, and batch production/testing records to ensure compliance with cGMP operations.
• Oversee and review executed electronic and paper batch record documentation.
• Review manufacturing deviations and enforce adherence to current good manufacturing practices, SOPs, and manufacturing documentation and operations including modeling clean room behaviors.  
• Establish and follow written procedures for the clear and accurate documentation of equipment operation, process instructions, and process data.
• Responsible for training adherence
• Adherence to data integrity principles
• Escalation of manufacturing, safety and quality concerns to department management
• Monitor process operations to ensure compliance with specifications.
• Practice safe work habits and adhere to safety procedures and guidelines.
• Utilize knowledge to improve operational efficiency.
• Participate in the quality oversight of manufacturing through real-time observations of activities.
• Oversee review and release of Raw Materials and streamline procedures for the rejection and destruction of Raw Materials and Consumables.
• Identify, classify, and report deviations as appropriate.
• Develop batch records, SOPs, and training materials for startup activities.
• Participate in internal audits for compliance with SOPs, GMPs, and regulations.  Basic understanding of health authority regulations and how to apply them internally.
• Leads projects with cross functional teams, able to lead and manage projects end to end.
• Ability to contribute to continuous improvement projects and support multiple projects at the same time.
• Act as a SME and resource for new hires
• Problem solving for complex issues and ability to drive corrective action

Qualifications

• Education: Bachelor’s Degree or equivalent years of experience
• Experience: 2-5 Years experience in the biotechnology/biopharmaceutical industry, or other regulated industry, Preferably in Quality Assurance and/or Training / document control.

Other Quantifiable Preference

• Knowledge of FDA, EU, ICH guidelines, and relevant regulations.
• Experience with quality systems, including batch record review, deviation management, and change control.
• Proficiency in authoring and reviewing GMP documentation.
• Familiarity with environmental monitoring and microbiological testing.

Scheudle:

first shift role with Sunday-Wednesday schedule. It is 100% onsite.

Job Type & Location

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

The pay range for this position is $42.00 - $52.00/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)

This is a fully onsite position in Dedham,MA.

This position is anticipated to close on Aug 7, 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 [email protected] 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.