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.
• Support Quality Assurance leadership in conducting departmental training and facilitating efficient workflow within the QA department.
• Work closely with Quality Assurance leadership to streamline existing processes and develop new processes and procedures that enhance business efficiency and compliance.
• Assist Quality Assurance leadership in preparing and presenting regular updates to site leadership through formal Management Review, including quality metrics, trends, and key elements of the quality assurance program.

Essential Skills

• Minimum of 5 years 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.

This is a Contract to Hire position based out of Centerbrook, CT.

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)

This is a fully onsite position in Centerbrook,CT.

This position is anticipated to close on May 18, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

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.

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.

Salary : $26 - $31