Senior Document Control Specialist

Document Control Specialist (cGMP Environment)

Overview:

We are seeking a detail-oriented Document Control Specialist responsible for maintaining quality documentation and managing document control systems. This role ensures compliance with current Good Manufacturing Practices (cGMP) and applicable regulatory standards, including USFDA 21 CFR Parts 210 and 211, as well as ICH Q7 guidelines for Active Pharmaceutical Ingredients (API).

Key Responsibilities:

+ Administer and maintain document control systems to ensure accuracy, integrity, and compliance with cGMP requirements

+ Manage master indices and tracking for key quality documents, including:

+ Standard Operating Procedures (SOPs)

+ Deviation reports

+ Change control records

+ Technical reports and protocols

+ Batch records

+ Validation and non-conformance reports

+ Coordinate documentation workflows to ensure timely drafting, review, approval, and issuance of documents

+ Ensure all documentation is properly indexed, filed, archived, and retrievable in alignment with company policies

+ Support the development, review, approval, and issuance of quality system documents

+ Assist in updating procedures related to the Documentation function

+ Partner with cross-functional teams to support documentation needs, including retrieval of quality records and data for audits and inspections

+ Contribute to continuous improvement initiatives within quality and documentation processes

+ Maintain a high level of accuracy with strong attention to detail and self-review practices

Qualifications:

+ Associate degree in a scientific discipline or equivalent experience

+ 1-3 years of experience with documentation systems, preferably within an FDA-regulated or pharmaceutical environment

+ Strong organizational and time management skills

+ Proficiency in Microsoft Word, Excel, and Access

+ Ability to work collaboratively across departments

If interested, please reach out directly to Lindsee Allienello at lallienello @

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.

Final date to receive applications

This position is anticipated to close on Jun 23, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 actalentaccom 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.