Compliance Specialist

Compliance Associate The Compliance Associate supports the Quality Assurance department in maintaining and continuously improving a cGMP-compliant Quality Management System (QMS). This role focuses on document control, training administration, regulatory compliance activities, audit support, complaint investigations, and customer documentation requests. The Compliance Associate works closely with cross-functional teams to ensure adherence to internal quality standards and applicable regulatory requirements while driving ongoing continuous improvement initiatives. Responsibilities Support the administration and maintenance of the Quality Management System (QMS) to ensure ongoing compliance with cGMP and internal quality standards. Monitor and interpret FDA, state, and relevant certification requirements, and clearly communicate compliance expectations to internal stakeholders. Maintain regulatory data, registrations, listings, and compliance records in an accurate and timely manner. Conduct routine compliance assessments and assist in identifying risks, implementing corrective and preventive actions (CAPAs), and verifying their effectiveness. Participate in internal and external audits, including preparation, documentation, on-site support, and follow-up activities. Serve as a primary point of contact for customer requests related to quality, regulatory, and supplier qualification documentation. Prepare, review, revise, and maintain quality system documentation, including standard operating procedures (SOPs), work instructions, and other controlled documents. Process, investigate, and track customer complaints while ensuring compliance with applicable quality and regulatory requirements. Conduct root cause investigations and coordinate corrective actions with cross-functional teams to address quality issues and prevent recurrence. Maintain employee training records and support training compliance initiatives to ensure personnel remain current with applicable requirements. Track and manage quality records, including deviations, change controls, CAPAs, complaints, and audit documentation. Oversee document lifecycle activities, including creation, review, approval, distribution, archival, and retention of controlled documents. Assist in the collection, analysis, and reporting of quality metrics used to evaluate the effectiveness of the quality system. Support continuous improvement initiatives within the Quality Assurance department by identifying opportunities to enhance processes and controls. Perform additional quality and compliance-related duties as assigned to support departmental and organizational objectives. Essential Skills Experience in Quality Assurance, Compliance, Regulatory Affairs, or a related function within a regulated industry preferred. Knowledge of cGMP requirements and quality systems preferred. Familiarity with FDA regulations and quality management principles is a plus. Experience with document control systems and quality management systems preferred. Exposure to CAPA, deviations, complaints, audits, training management, and change control processes. Strong attention to detail and excellent organizational skills. Ability to manage multiple priorities in a fast-paced environment. Strong analytical and problem-solving abilities, including root cause analysis and data review. Proficiency in Microsoft Office Suite and data entry for quality and compliance records. Excellent written and verbal communication skills, including clear written correspondence with internal and external stakeholders. Ability to work both independently and collaboratively with cross-functional teams. Demonstrated sense of ownership, accountability, and commitment to quality and compliance. Additional Skills & Qualifications Associate's or Bachelor's degree in Life Sciences, Chemistry, Biology, Regulatory Affairs, Quality Assurance, or a related field preferred. Relevant industry experience may be considered in lieu of a degree. Experience working in pharmaceutical, nutraceutical, medical device, food manufacturing, or other regulated environments is highly desirable. Experience with quality control, finished product review, batch record review, and closing documents is beneficial. Familiarity with medical device and pharmaceutical compliance regulations is advantageous. Customer service experience, particularly in handling customer complaints and documentation requests, is beneficial. Ability to interpret regulatory requirements and translate them into practical quality and compliance processes. Work Environment This role operates primarily in an office and laboratory environment within a medium-sized company. The position involves regular use of computers, document control systems, and common office software to manage quality records, training documentation, and regulatory data. Collaboration with Quality Assurance, Regulatory, and other cross-functional teams is frequent, fostering a friendly and supportive work culture. The organization offers paid time off (PTO) and holidays, contributing to a balanced work–life environment. Job Type & Location This is a Contract to Hire position based out of Centerbrook, CT. Pay and Benefits The pay range for this position is $31.00 - $36.00/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 Centerbrook,CT. Application Deadline This position is anticipated to close on Jul 2, 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 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.