About this role
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 timelinesServe as the document lifecycle manager for QMS documents, including SOPs, policies, and related controlled recordsPerform detailed documentation reviews to ensure consistency in language, formatting, and overall quality standardsSupport 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 initiativesCollaborate with internal stakeholders to ensure documentation and training requirements are clearly understood and properly executed Required:
Bachelor’s degree in an appropriate scientific or business field of studyMinimum of six (6) years of experience in the pharmaceutical or equivalent regulated industryStrong technical proficiency in MS Word document editing, including formatting, forms, styles, and templatesTechnical writing and/or editing experience in a GxP‑regulated environmentStrong attention to detail with the ability to ensure accuracy and consistency in controlled documentationAbility to manage multiple tasks simultaneously, prioritize effectively, and meet deadlinesAbility to follow written procedures and instructions accuratelyDemonstrated ability to work both independently and collaboratively within a team environmentSelf‑motivated with the ability to adapt to changing priorities and timelinesPositive attitude with flexibility to support shifting business needsExperience navigating and using an electronic document management system (e.g., MEDS, QDocs) within a GMP environmentPreferred:
Excellent verbal and written communication skills, including presentation skillsStrong cross‑functional collaboration and teamwork skillsExperience directly related to Quality Assurance and/or Quality ControlPreferred experience developing, authoring, or revising Standard Operating Procedures (SOPs) 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 Recruiter45-60 Minute Virtual Interview with Manager and/or Group LeaderWhat We Offer:
Excellent full-time benefits, including comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysYearly goal-based bonus & eligibility for merit-based increasesEurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.