Senior Document Control Specialist

Description

This role is responsible for maintaining quality documentation and managing document control systems at the site to ensure adherence to Current Good Manufacturing Practices (cGMP) and compliance with regulatory standards, including USFDA Title 21 CFR Parts 210 and 211, as well as Q7 Good Manufacturing Practice guidance for active pharmaceutical ingredients.

Skills

Document control, deviation management, batch record, gmp, change control, sop, Data entry, Quality assurance, Documentation management

Top Skills Details

Document control,deviation management,batch record,gmp,change control,sop

Additional

Skills & Qualifications

Manages document control systems and processes to ensure their integrity and compliance with cGMP regulations. o Maintains master indices and tracking of standard operating procedures, deviations reports, change control reports, technical reports, protocols, batch record files, validation reports and non-conformance reports. o Coordinates documentation activities to ensure that procedures are written, edited, reviewed and approved in a timely manner to meet established deadlines.

Ensure that documentation/records are indexed, filed, archived, retrievable and issued, consistent with procedures and policies - Assist in the development, approval, and issuance of quality system documents.

- Assist in updating procedures specific to the Documentation Department.

- Works closely with other departments to support their documentation activities. This includes the retrieving of quality documents/records/trend data and any other documentation requested during these inspections - Assist in continuous improvement initiatives.

- Strong attention to detail and self-checking skills The job requires a minimum of a associate degree in the sciences or equivalent and at least 1-3 years' experience in documentation systems preferable in an FDA regulated industry.

- Must have good organizational skills.

- Solid skills with Microsoft Word, Access, and Excel.

Experience Level

Entry Level

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 15, 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.