Documentation Specialist
Eurofins PSS Insourcing Solutions, West Point, PA, United States
Job Description
This position provides support for the implementation, maintenance, and ongoing compliance of cGMP documentation and training systems. The role works closely with Quality and cross‑functional stakeholders to ensure accurate document control, consistent formatting and language, and effective training administration in accordance with applicable regulatory requirements.
Key Responsibilities
Coordinate the revision, review, and approval of cGMP documents, ensuring compliance with applicable regulations and established timelines.
Serve as the document lifecycle manager for QMS documents, including SOPs, policies, and related controlled records.
Perform detailed documentation reviews to ensure consistency in language, formatting, and overall quality standards.
Support training administration activities, including creating and assigning training, granting training credit, and running training reports within the Learning Management System (LMS).
Assist with maintaining accurate documentation and training records to support inspections, audits, and internal quality initiatives.
Collaborate with internal stakeholders to ensure documentation and training requirements are clearly understood and properly executed.
Qualifications Required:
Bachelor’s degree in an appropriate scientific or business field of study.
Minimum of six (6) years of experience in the pharmaceutical or equivalent regulated industry.
Strong technical proficiency in MS Word document editing, including formatting, forms, styles, and templates.
Technical writing and/or editing experience in a GxP‑regulated environment.
Strong attention to detail with the ability to ensure accuracy and consistency in controlled documentation.
Ability to manage multiple tasks simultaneously, prioritize effectively, and meet deadlines.
Ability to follow written procedures and instructions accurately.
Demonstrated ability to work both independently and collaboratively within a team environment.
Self‑motivated with the ability to adapt to changing priorities and timelines.
Positive attitude with flexibility to support shifting business needs.
Experience navigating and using an electronic document management system (e.g., MEDS, QDocs) within a GMP environment.
Preferred:
Excellent verbal and written communication skills, including presentation skills.
Strong cross‑functional collaboration and teamwork skills.
Experience directly related to Quality Assurance and/or Quality Control.
Preferred experience developing, authoring, or revising Standard Operating Procedures (SOPs).
Additional Information The position is
Full Time, Monday through Friday, 8am-5pm . Candidates currently living within a commutable distance of
West Point, PA
are encouraged to apply.
What to Expect in the Hiring Process
10‑15 Minute Phone Interview with Regional Recruiter.
45‑60 Minute Virtual Interview with Manager and/or Group Leader.
What We Offer
Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options.
Life and disability insurance.
401(k) with company match.
Paid vacation and holidays.
Yearly goal‑based bonus & eligibility for merit‑based increases.
EEO Statement Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
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Key Responsibilities
Coordinate the revision, review, and approval of cGMP documents, ensuring compliance with applicable regulations and established timelines.
Serve as the document lifecycle manager for QMS documents, including SOPs, policies, and related controlled records.
Perform detailed documentation reviews to ensure consistency in language, formatting, and overall quality standards.
Support training administration activities, including creating and assigning training, granting training credit, and running training reports within the Learning Management System (LMS).
Assist with maintaining accurate documentation and training records to support inspections, audits, and internal quality initiatives.
Collaborate with internal stakeholders to ensure documentation and training requirements are clearly understood and properly executed.
Qualifications Required:
Bachelor’s degree in an appropriate scientific or business field of study.
Minimum of six (6) years of experience in the pharmaceutical or equivalent regulated industry.
Strong technical proficiency in MS Word document editing, including formatting, forms, styles, and templates.
Technical writing and/or editing experience in a GxP‑regulated environment.
Strong attention to detail with the ability to ensure accuracy and consistency in controlled documentation.
Ability to manage multiple tasks simultaneously, prioritize effectively, and meet deadlines.
Ability to follow written procedures and instructions accurately.
Demonstrated ability to work both independently and collaboratively within a team environment.
Self‑motivated with the ability to adapt to changing priorities and timelines.
Positive attitude with flexibility to support shifting business needs.
Experience navigating and using an electronic document management system (e.g., MEDS, QDocs) within a GMP environment.
Preferred:
Excellent verbal and written communication skills, including presentation skills.
Strong cross‑functional collaboration and teamwork skills.
Experience directly related to Quality Assurance and/or Quality Control.
Preferred experience developing, authoring, or revising Standard Operating Procedures (SOPs).
Additional Information The position is
Full Time, Monday through Friday, 8am-5pm . Candidates currently living within a commutable distance of
West Point, PA
are encouraged to apply.
What to Expect in the Hiring Process
10‑15 Minute Phone Interview with Regional Recruiter.
45‑60 Minute Virtual Interview with Manager and/or Group Leader.
What We Offer
Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options.
Life and disability insurance.
401(k) with company match.
Paid vacation and holidays.
Yearly goal‑based bonus & eligibility for merit‑based increases.
EEO Statement Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
#J-18808-Ljbffr