Senior Document Control Specialist

Job Description

Job Description

Job Title: Senior Document Control Specialist

Job Description

The Senior Document Control Specialist maintains quality documentation and manages site-wide document control systems to ensure full adherence to Current Good Manufacturing Practices (cGMP) and compliance with regulatory standards, including USFDA Title 21 CFR Parts 210 and 211 and Q7 Good Manufacturing Practice guidance for active pharmaceutical ingredients. This role supports manufacturing and quality operations by ensuring that all controlled documents and records are accurate, current, traceable, and readily accessible for internal use and regulatory inspections.

Responsibilities

• Manage document control systems and processes to ensure their integrity and compliance with cGMP regulations and applicable regulatory standards.
• Maintain master indices and tracking for standard operating procedures, deviation reports, change control reports, technical reports, protocols, batch record files, validation reports, and non-conformance reports.
• Coordinate documentation activities so that procedures and quality system documents are written, edited, reviewed, and approved in a timely manner to meet established deadlines.
• Ensure all documentation and records are properly indexed, filed, archived, retrievable, and issued in accordance with established procedures and policies.
• Assist in the development, approval, and issuance of quality system documents, including SOPs and related controlled documents.
• Assist in updating procedures specific to the Documentation Department to reflect process improvements and regulatory expectations.
• Work closely with other departments to support their documentation activities, including retrieving quality documents, records, trend data, and other documentation requested during inspections and audits.
• Support continuous improvement initiatives related to documentation management and quality systems.
• Process the revision and review of documents in a timely manner to ensure that current versions are available and obsolete versions are properly controlled.
• Assist the Senior Documentation Coordinator with daily activities that support manufacturing documentation needs.
• Maintain records and documents in accordance with regulations and internal procedures, ensuring accuracy, completeness, and traceability.
• Collaborate with plant staff to improve and strengthen compliance with cGMP, regulatory requirements, and internal procedures and policies.
• Provide excellent customer service to internal stakeholders by responding promptly and professionally to documentation-related requests.
• Apply strong attention to detail and self-checking skills to identify and correct errors or inconsistencies in documentation.
• Perform data entry and documentation management tasks to support quality assurance and batch record review activities.

Essential Skills

• Minimum of an associate degree in the sciences or an equivalent qualification.
• At least 1–3 years of experience working with documentation systems, preferably in an FDA-regulated industry.
• Hands-on experience with document control, including managing controlled documents and records in a cGMP environment.
• Experience with deviation management, including documentation and tracking of deviations.
• Experience with batch record documentation and batch record review.
• Knowledge of change control processes and related documentation requirements.
• Understanding of Current Good Manufacturing Practices (cGMP) and regulatory standards, including USFDA Title 21 CFR Parts 210 and 211 and Q7 GMP guidance.
• Experience with quality assurance documentation and documentation management practices.
• Strong data entry skills with a focus on accuracy and completeness.
• Strong attention to detail and self-checking skills to ensure high-quality documentation.
• Good organizational skills, including the ability to manage multiple documents, indices, and tracking systems.
• Solid skills with Microsoft Word, Microsoft Access, and Microsoft Excel.
• Ability to work closely with cross-functional teams and plant staff to support documentation needs and compliance.

Additional Skills & Qualifications

• Experience working with SOP tracking systems and processes.
• Familiarity with SOP authoring, editing, and lifecycle management.
• Exposure to validation reports, technical reports, protocols, and non-conformance reports in a regulated environment.
• Experience supporting inspections and audits by retrieving and organizing documentation and trend data.
• Background in an FDA-regulated industry such as pharmaceuticals, biotechnology, or related manufacturing.
• Demonstrated ability to support continuous improvement initiatives within documentation or quality systems.
• Customer service mindset with the ability to respond promptly and professionally to internal documentation requests.

Work Environment

The Senior Document Control Specialist works closely with plant staff and cross-functional teams in a regulated manufacturing environment focused on compliance with cGMP and regulatory requirements. The role involves extensive work with electronic and paper-based documentation, including SOPs, batch records, deviation reports, change control documentation, validation reports, and other quality records. Daily work relies on standard office and computer tools, particularly Microsoft Word, Access, and Excel, to manage document control systems, perform data entry, and maintain indices and tracking logs. The environment emphasizes accuracy, timeliness, and adherence to established procedures and policies, with frequent collaboration to support manufacturing operations, quality assurance activities, and regulatory inspections. The position carries accountability for maintaining records and documents in compliance with regulations and internal procedures while providing responsive and professional support to internal customers.

Job Type & Location

This is a Contract position based out of Milford, MA.

Pay and Benefits

The pay range for this position is $20.00 - $24.00/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 Milford,MA.

Application Deadline

This position is anticipated to close on Jun 26, 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.