Compliance Analyst

Job Title: Compliance Analyst

Job Description

The Quality Assurance Associate assists in the management, administration, and maintenance of the Quality System to ensure compliance with internal standards and external regulatory requirements. This role is responsible for verifying that products are manufactured in accordance with applicable procedures and specifications in a cGMP-compliant manner. The associate partners closely with manufacturing and operations throughout the production life cycle to ensure procedures are followed, activities are appropriately documented, and products are released in alignment with quality and regulatory expectations.

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 complete, accurate, and available to support production activities.
• Routinely review production floor activities and documentation to verify compliance with established procedures and quality requirements.
• Stay current with 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 conducting training related to quality procedures, documentation practices, and shop floor compliance.
• Manage quality events associated with production activities by using risk-based principles to assess events, determine appropriate actions, and ensure timely and thorough resolution.
• Manage deviations by coordinating, documenting, and supporting investigations as required, ensuring that root causes and corrective actions are clearly defined.
• Review completed batch records and perform product release activities as authorized by the Quality Assurance leadership, ensuring all quality and regulatory requirements are met prior to release.
• Ensure proper filing, storage, and control of quality documentation to maintain data integrity, traceability, and audit readiness.
• Sample raw materials and packaging components as needed to help the department meet quality and production timelines.
• Author and edit SOPs in collaboration with Quality Assurance leadership to ensure procedures are clear, current, and aligned with regulatory expectations.
• Support Quality Assurance leadership in conducting departmental training and facilitating workflow within the quality function to improve efficiency and consistency.
• Work closely with Quality Assurance leadership to streamline existing processes and develop new processes and procedures that enhance business performance and quality outcomes.
• Support the preparation and regular presentation of quality assurance program elements, including metrics and trends, to site leadership through formal Management Review.

Essential Skills

• Minimum 3 years of experience in quality assurance within a drug and/or cGMP-regulated environment.
• Demonstrated experience with cGMP requirements and their application in a manufacturing setting.
• Hands-on experience with batch record issuance, review, and product release activities.
• Experience managing quality events and deviations, including coordinating and documenting investigations.
• Knowledge of quality assurance and quality control principles, including document control, audits, CAPA, and inspection readiness.
• Strong sense of ownership and accountability for quality outcomes and compliance.
• Proven ability to build partnerships and collaborate effectively with production and other departments.
• Strong attention to detail with the ability to identify and correct documentation and process issues.
• Excellent oral and written communication skills to interact with cross-functional teams and document quality activities clearly.
• General knowledge and exposure to manufacturing equipment and processes in a regulated environment.
• Ability to work with minimal supervision while prioritizing and managing multiple projects and tasks.
• Flexibility and a strong work ethic, with the ability to respond quickly to changing business and production needs.
• A proactive, “do whatever is necessary” attitude to support production and quality objectives.

Additional Skills & Qualifications

• Experience in a FDA-regulated environment, including familiarity with inspection expectations and practices.
• Exposure to food safety principles and their application in a manufacturing or processing environment.
• Experience participating in or supporting internal and external quality audits.
• Familiarity with CAPA processes, including identification, implementation, and verification of corrective and preventive actions.
• Experience contributing to or presenting quality metrics and trends to leadership.
• Prior involvement in authoring, revising, or maintaining SOPs and other controlled quality documents.

Work Environment

The role is based in a cGMP-regulated manufacturing environment that requires close collaboration with production and operations teams on the shop floor. The Quality Assurance Associate regularly interacts with manufacturing equipment and processes, reviews documentation generated in real time during production, and supports ongoing compliance with SOPs related to cleaning, room conditions, changeovers, and line clearance. The position involves a mix of office-based document review and floor-based oversight, with an expectation of responsiveness to production needs and timelines. The work environment emphasizes regulatory compliance, audit readiness, and continuous improvement of quality processes.

If interested please book a virtual meeting with me here: https://talentassistant.actalentservices.com/assistant/bookings/bgF9HVkt

This is a Permanent position based out of Centerbrook, CT.

The pay range for this position is $65000.00 - $75000.00/yr.

PTO, Holiday, Sick time. Matching 401K

This is a fully onsite position in Centerbrook,CT.

This position is anticipated to close on Aug 14, 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 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.

Salary : $65,000 - $75,000