Documentation Specialist
Eurofins USA 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 timelinesPositive 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
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
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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 timelinesPositive 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
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
#J-18808-Ljbffr