Documentation Specialist

This position provides support for the implementation maintenance and ongoing compliance of cGMP documentation and training systems. The role works closely with Quality and crossfunctional 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:

• Bachelors 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 GxPregulated 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
• Selfmotivated 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 crossfunctional 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.

Remote Work :

No

Employment Type :

Full-time