Senior GMP Documentation & Compliance 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. Additional Skills & Qualifications Manages document control systems and processes to ensure their integrity and compliance with cGMP regulations. 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. Coordinates documentation activities to ensure that procedures are written, edited, reviewed and approved in a timely manner to meet established deadlines. Ensures documentation/records are indexed, filed, archived, retrievable and issued, consistent with procedures and policies. Assists in the development, approval, and issuance of quality system documents. Assists in updating procedures specific to the Documentation Department. Works closely with other departments to support their documentation activities, including retrieving quality documents/records/trend data and documentation requested during inspections. Assists in continuous improvement initiatives. Strong attention to detail and self-checking skills. The job requires a minimum of an 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 and solid skills with Microsoft Word, Access, and Excel. 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 & Benefits Eligibility requirements apply to some benefits and may depend on 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&DD 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. Equal Opportunity Employer 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 View email address on click.appcast.io for other accommodation options. 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. #J-18808-Ljbffr Actalent