Quality Assurance Specialist

Quality Assurance Specialist II Location: Bedford, MA Schedule: Monday - Friday 8am - 4pm Industry: Biotechnology / Medical Device About The Role We are seeking a Quality Assurance Specialist to support quality and compliance activities within a regulated manufacturing environment. This individual will play a key role in ensuring products and processes meet cGMP, FDA, and

ISO 13485

requirements while maintaining the integrity of the Quality Management System (QMS). The ideal candidate will have experience in quality assurance, batch record review, investigations, and compliance within the life sciences, biotechnology, pharmaceutical, or medical device industry. Responsibilities Support and maintain compliance with cGMP, FDA, and ISO 13485 quality requirements. Review, approve, and release batch production records and raw materials. Lead and support deviation investigations, root cause analysis, and corrective actions. Ensure quality documentation is accurate, complete, and compliant with regulatory requirements. Assist with document control activities and maintenance of quality records. Support internal and external audits, including regulatory inspections. Partner with cross-functional teams to resolve quality issues and drive continuous improvement initiatives. Contribute to the ongoing development, maintenance, and effectiveness of the Quality Management System (QMS). Monitor compliance trends and recommend improvements to quality processes and procedures. Provide quality support to manufacturing, operations, and other functional groups as needed. Qualifications Bachelor's degree in Biology, Chemistry, Biotechnology, Life Sciences, or a related field. 3–5 years of Quality Assurance experience in a regulated pharmaceutical, biotechnology, or medical device environment. Experience working within cGMP, FDA, and ISO 13485 regulated environments. Strong understanding of Quality Management Systems (QMS). Experience reviewing batch records and supporting product release activities. Proven experience conducting investigations, deviation management, and root cause analysis. Strong attention to detail and documentation skills. Excellent communication and cross-functional collaboration abilities. Preferred Skills Quality Assurance Compliance Management Batch Record Review & Release Deviation Management Investigations & Root Cause Analysis GMP Compliance Document Control Quality Management Systems (QMS) FDA Regulations ISO 13485 Why Apply? Opportunity to join a growing organization focused on quality and regulatory excellence. High-impact role supporting compliance and product quality initiatives. Collaborative environment with cross-functional exposure. Competitive compensation and career growth opportunities. Job Type & Location This is a Contract position based out of Bedford, MA. Pay And Benefits The pay range for this position is $30.00 - $33.00/hr. Benefits 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 Bedford, MA. Application Deadline This position is anticipated to close on Jul 22, 2026. Equal Opportunity 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 View email address on click.appcast.io 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. #J-18808-Ljbffr Actalent