Document Control Specialist
Actalent, Centerbrook, CT, United States
Job Title: Quality Assurance Associate
Job Description
The Quality Assurance Associate supports the maintenance and execution of a cGMP-compliant Quality Management System with a strong focus on document control, training, complaints, audits, and regulatory compliance. This role plays a key part in ensuring products and processes meet applicable FDA regulations and internal quality standards while collaborating closely with cross-functional teams in an office and laboratory environment.
Responsibilities
Maintain and support all aspects of the cGMP Quality Management System to ensure ongoing compliance with internal procedures and regulatory requirements.
Manage document control activities, including the creation, review, revision, issuance, and archival of standard operating procedures (SOPs), batch records, specifications, change controls, corrective and preventive actions (CAPAs), and investigation reports.
Track, review, distribute, archive, and retire controlled documents in a timely and accurate manner to maintain a current and compliant documentation system.
Support the planning and execution of internal audits, customer audits, and FDA inspections by preparing documentation, coordinating responses, and participating in audit activities.
Assist with regulatory compliance initiatives and certification requirements by gathering data, preparing reports, and supporting the implementation of compliance programs.
Process, document, and investigate customer complaints, deviations, and adverse events, ensuring timely follow-up, accurate data entry, and appropriate escalation when needed.
Support corrective and preventive action (CAPA) investigations by collecting information, assisting with root cause analysis, documenting findings, and tracking action items to closure.
Maintain employee training records, track training completion, and support the coordination and documentation of quality and compliance training programs.
Coordinate customer documentation requests and support the preparation of regulatory submissions by assembling required records, reports, and supporting information.
Support vendor qualification activities, including collection and review of raw material documentation, maintenance of quality agreements, and coordination with suppliers as needed.
Assist with product labeling review, regulatory reporting, and other compliance programs to ensure that finished products meet applicable regulatory and quality requirements.
Monitor regulatory updates, guidance documents, and industry standards, and help assess their impact on existing quality systems, procedures, and documentation.
Perform accurate data entry, data review, and reporting related to quality metrics, batch records, finished product documentation, and closing documents.
Prepare clear written correspondence and reports related to quality issues, customer complaints, investigations, and regulatory matters.
Collaborate with internal teams to support quality control, pharmaceutical and medical device compliance, and continuous improvement of quality processes.
Essential Skills
Experience in Quality Assurance or Compliance within a cGMP environment.
Working knowledge of FDA regulations, including 21 CFR Parts 111, 211, and 820.
Hands-on experience with document control processes for SOPs, batch records, specifications, change controls, CAPAs, and investigations.
Understanding of quality control principles and cGMP Quality Management Systems.
Ability to process and investigate customer complaints, deviations, and adverse events with strong customer service skills.
Familiarity with CAPA processes and root cause analysis methodologies.
Strong attention to detail and excellent organizational skills.
Ability to manage multiple priorities and tasks with minimal supervision.
Strong written and verbal communication skills for clear reporting and correspondence.
Proficiency in Microsoft Office applications for documentation, data entry, and reporting.
Ability to perform accurate data review of batch records, finished product documentation, and quality reports.
Additional Skills & Qualifications
College degree strongly preferred, ideally in a scientific, technical, or related discipline.
Experience working in pharmaceutical, medical device, or related regulated industries.
Knowledge of compliance regulations and regulatory reporting requirements.
Experience supporting internal, customer, and FDA audits and inspections.
Familiarity with vendor qualification processes, raw material documentation, and quality agreements.
Ability to monitor regulatory updates and assess their impact on quality systems and procedures.
Strong analytical skills to support investigations, data review, and continuous improvement activities.
Comfort working with training systems and maintaining employee training records.
Ability to produce clear written correspondence to customers and regulatory stakeholders.
Work Environment
This role operates in a combined office and laboratory environment within a medium-sized company setting. The position involves extensive work with electronic and paper-based quality documentation, Microsoft Office tools, and quality system records related to pharmaceutical and medical device products. You will collaborate with friendly staff in a professional, compliance-focused culture that values accuracy, accountability, and teamwork. The schedule follows standard business hours, with work primarily performed on-site in office and lab areas. The organization offers paid time off and holidays as part of its benefits, contributing to a supportive and balanced work environment.
If you are interested please book a virtual meeting with me: https://talentassistant.actalentservices.com/assistant/bookings/bgF9HVkt
Job Type & Location
This is a Contract 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 May 8, 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.
Job Description
The Quality Assurance Associate supports the maintenance and execution of a cGMP-compliant Quality Management System with a strong focus on document control, training, complaints, audits, and regulatory compliance. This role plays a key part in ensuring products and processes meet applicable FDA regulations and internal quality standards while collaborating closely with cross-functional teams in an office and laboratory environment.
Responsibilities
Maintain and support all aspects of the cGMP Quality Management System to ensure ongoing compliance with internal procedures and regulatory requirements.
Manage document control activities, including the creation, review, revision, issuance, and archival of standard operating procedures (SOPs), batch records, specifications, change controls, corrective and preventive actions (CAPAs), and investigation reports.
Track, review, distribute, archive, and retire controlled documents in a timely and accurate manner to maintain a current and compliant documentation system.
Support the planning and execution of internal audits, customer audits, and FDA inspections by preparing documentation, coordinating responses, and participating in audit activities.
Assist with regulatory compliance initiatives and certification requirements by gathering data, preparing reports, and supporting the implementation of compliance programs.
Process, document, and investigate customer complaints, deviations, and adverse events, ensuring timely follow-up, accurate data entry, and appropriate escalation when needed.
Support corrective and preventive action (CAPA) investigations by collecting information, assisting with root cause analysis, documenting findings, and tracking action items to closure.
Maintain employee training records, track training completion, and support the coordination and documentation of quality and compliance training programs.
Coordinate customer documentation requests and support the preparation of regulatory submissions by assembling required records, reports, and supporting information.
Support vendor qualification activities, including collection and review of raw material documentation, maintenance of quality agreements, and coordination with suppliers as needed.
Assist with product labeling review, regulatory reporting, and other compliance programs to ensure that finished products meet applicable regulatory and quality requirements.
Monitor regulatory updates, guidance documents, and industry standards, and help assess their impact on existing quality systems, procedures, and documentation.
Perform accurate data entry, data review, and reporting related to quality metrics, batch records, finished product documentation, and closing documents.
Prepare clear written correspondence and reports related to quality issues, customer complaints, investigations, and regulatory matters.
Collaborate with internal teams to support quality control, pharmaceutical and medical device compliance, and continuous improvement of quality processes.
Essential Skills
Experience in Quality Assurance or Compliance within a cGMP environment.
Working knowledge of FDA regulations, including 21 CFR Parts 111, 211, and 820.
Hands-on experience with document control processes for SOPs, batch records, specifications, change controls, CAPAs, and investigations.
Understanding of quality control principles and cGMP Quality Management Systems.
Ability to process and investigate customer complaints, deviations, and adverse events with strong customer service skills.
Familiarity with CAPA processes and root cause analysis methodologies.
Strong attention to detail and excellent organizational skills.
Ability to manage multiple priorities and tasks with minimal supervision.
Strong written and verbal communication skills for clear reporting and correspondence.
Proficiency in Microsoft Office applications for documentation, data entry, and reporting.
Ability to perform accurate data review of batch records, finished product documentation, and quality reports.
Additional Skills & Qualifications
College degree strongly preferred, ideally in a scientific, technical, or related discipline.
Experience working in pharmaceutical, medical device, or related regulated industries.
Knowledge of compliance regulations and regulatory reporting requirements.
Experience supporting internal, customer, and FDA audits and inspections.
Familiarity with vendor qualification processes, raw material documentation, and quality agreements.
Ability to monitor regulatory updates and assess their impact on quality systems and procedures.
Strong analytical skills to support investigations, data review, and continuous improvement activities.
Comfort working with training systems and maintaining employee training records.
Ability to produce clear written correspondence to customers and regulatory stakeholders.
Work Environment
This role operates in a combined office and laboratory environment within a medium-sized company setting. The position involves extensive work with electronic and paper-based quality documentation, Microsoft Office tools, and quality system records related to pharmaceutical and medical device products. You will collaborate with friendly staff in a professional, compliance-focused culture that values accuracy, accountability, and teamwork. The schedule follows standard business hours, with work primarily performed on-site in office and lab areas. The organization offers paid time off and holidays as part of its benefits, contributing to a supportive and balanced work environment.
If you are interested please book a virtual meeting with me: https://talentassistant.actalentservices.com/assistant/bookings/bgF9HVkt
Job Type & Location
This is a Contract 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 May 8, 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.