<p>Job Title: Quality Assurance Associate</p> <p>Job Description</p> <p>We are seeking a dedicated Quality Assurance Associate to support the maintenance and execution of a cGMP compliant Quality Management System. This role focuses on document control, training, complaints, audits, and regulatory compliance to ensure high standards are upheld.</p> <p>Responsibilities</p> <ul> <li>Maintain and support cGMP Quality Management System activities. </li><li>Manage document control including SOPs, batch records, specifications, change controls, CAPAs, and investigations. </li><li>Track, review, distribute, archive, and obsolete controlled documents. </li><li>Support internal, customer, and FDA audits. </li><li>Assist with regulatory compliance activities and certification requirements. </li><li>Process and investigate customer complaints, deviations, and adverse events. </li><li>Support corrective and preventive action investigations. </li><li>Maintain employee training records and support training programs. </li><li>Coordinate customer documentation requests and regulatory submissions. </li><li>Support vendor qualification, raw material documentation, and quality agreements. </li><li>Assist with product labeling, regulatory reporting, and compliance programs. </li><li>Monitor regulatory updates and assess impact to quality systems. </li></ul> <p>Essential Skills</p> <ul> <li>Experience in Quality Assurance or Compliance within a cGMP environment. </li><li>Working knowledge of FDA regulations including 21 CFR Parts 111, 211, and 820. </li><li>Strong attention to detail and organizational skills. </li><li>Ability to manage multiple priorities with minimal supervision. </li><li>Strong written and verbal communication skills. </li><li>Proficiency in Microsoft Office. </li></ul> <p>Additional Skills & Qualifications</p> <ul> <li>College degree strongly preferred. </li></ul> <p>Work Environment</p> <p>The work environment includes both office and laboratory settings. The company is medium-sized with a friendly staff and offers PTO and holidays.</p> <p>If you are interested please book a virtual meeting with me: https://talentassistant.actalentservices.com/assistant/bookings/bgF9HVkt</p> <p>Job Type & Location</p> <p>This is a Contract position based out of Centerbrook, CT.</p> <p>Pay and Benefits</p> <p>The pay range for this position is $31.00 - $36.00/hr.</p> <p>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:</p> <ul> <li>Medical, dental & vision </li><li>Critical Illness, Accident, and Hospital </li><li>401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available </li><li>Life Insurance (Voluntary Life & AD&D for the employee and dependents) </li><li>Short and long-term disability </li><li>Health Spending Account (HSA) </li><li>Transportation benefits </li><li>Employee Assistance Program </li><li>Time Off/Leave (PTO, Vacation or Sick Leave) </li></ul> <p>Workplace Type</p> <p>This is a fully onsite position in Centerbrook,CT.</p> <p>Application Deadline</p> <p>This position is anticipated to close on May 1, 2026.</p> <p>Diversity, Equity & Inclusion</p> <p>At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:</p> <ul> <li>Hiring diverse talent </li><li>Maintaining an inclusive environment through persistent self-reflection </li><li>Building a culture of care, engagement, and recognition with clear outcomes </li><li>Ensuring growth opportunities for our people </li></ul> <p>Actalent is an equal opportunity employer.</p> <p>About Actalent</p> <p>Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.</p> <p>Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.</p>