Quality Assurance Associate

Job Title:

Quality Assurance Associate Job Description The Quality Assurance Associate supports the management, administration, and maintenance of the Quality System to ensure compliance with internal procedures and external regulatory requirements. This role ensures that products are manufactured according to applicable procedures and specifications in a cGMP-compliant environment. The Quality Assurance Associate partners closely with manufacturing and operations throughout the production life cycle to verify that procedures are followed, activities are properly documented, and products are released in accordance with quality standards. Responsibilities Communicate and partner on a continuous, daily basis with production management to understand and support activities on the production floor. Issue batch records and ensure they are accurate, complete, and available to support production activities. Routinely review production floor activities and associated documentation to verify compliance with procedures, specifications, and cGMP requirements. Maintain current knowledge of applicable standard operating procedures (SOPs) related to shop floor practices, including cleaning, room conditions, changeovers, and line clearance, and verify ongoing compliance with these SOPs. Support production management in developing and delivering applicable training to production personnel. Manage all quality events associated with production activities, using risk-based principles to assess events and determine appropriate actions. Manage deviations and coordinate, document, and track investigations as required, ensuring timely and thorough resolution. Review completed batch records for accuracy, completeness, and compliance, and perform product release activities as authorized by Quality Assurance leadership. Ensure proper filing, organization, and secure storage of quality documentation and records. Sample raw materials and packaging components as needed to help the department meet workload and operational requirements. Perform other quality-related responsibilities and tasks as assigned to support departmental and organizational objectives. Collaborate with Quality Assurance leadership to author, revise, and edit standard operating procedures (SOPs) to maintain a robust and current Quality System. Essential Skills Minimum of 1 year of experience in quality assurance within a drug manufacturing and/or cGMP-regulated environment. Demonstrated experience with cGMP principles and their application in a production setting. Proficiency in quality assurance practices, including batch record review, quality control, audits, CAPA, and documentation oversight. Strong sense of ownership and accountability for quality outcomes and compliance. Proven ability to build partnerships and collaborate effectively with production and other cross-functional departments. Strong attention to detail with the ability to identify, document, and resolve discrepancies. Excellent oral and written communication skills for interacting with production staff, quality teams, and leadership. General knowledge and exposure to manufacturing equipment and production processes in a regulated environment. Ability to work with minimal supervision while managing priorities and multiple concurrent projects. Flexibility and a strong work ethic, with the ability to respond quickly to changing business needs and adopt a "do whatever is necessary" approach to support quality and operations. Additional Skills & Qualifications Experience managing quality events, including deviations and investigations, using risk-based principles. Experience supporting or conducting internal or external quality audits. Experience in authoring, revising, and maintaining SOPs within a regulated environment. Experience supporting or implementing CAPA (Corrective and Preventive Action) activities. Experience preparing and presenting quality metrics and trends to leadership as part of a formal quality review process. Comfort working in a fast-paced manufacturing environment with evolving priorities. Strong organizational skills for managing documentation, records, and multiple tasks simultaneously. Work Environment This role operates in a cGMP-regulated manufacturing environment where the Quality Assurance Associate works closely with production and operations teams on and around the production floor. The position involves frequent interaction with manufacturing equipment, production areas, and quality documentation systems. Work typically follows standard business hours, with the need for flexibility to respond to production and quality priorities. The environment emphasizes adherence to written procedures, documentation accuracy, and regulatory compliance, with a strong culture of collaboration, accountability, and continuous improvement.

Schedule :

Monday - Friday, 2nd Shift 3:50PM-12:20AM Candidates must be local in CT, role is 50% in office and 50% hands on in lab If you are interested please book a virtual meeting with me here: https://talentassistant.actalentservices.com/assistant/bookings/bgF9HVkt Job Type & Location This is a Contract to Hire position based out of Clinton, CT. Pay and Benefits The pay range for this position is $26.00 - $31.00/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) Workplace Type This is a fully onsite position in Clinton,CT.

Application Deadline This position is anticipated to close on May 22, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. 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.