Compliance Support Documentation Specialist

Bayer • Myerstown, PA

22h • $69,200 - $103,800 • Onsite

About The Position

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity, and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities, and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice. The Compliance Support Documentation Specialist will serve as the Subject Matter Expert (SME) for SOPs and Supplements within OTC and Nutritional Manufacturing and Packaging departments. This role provides specialized knowledge and technical support in quality assurance and control processes, analyzes quality data, develops best practices, and advises teams on compliance with industry standards and regulations. The specialist will collaborate with various departments to implement quality improvement initiatives and conduct training sessions, ensuring compliance, accuracy, standardization, and completeness of documentation supporting products manufactured and packaged at the Myerstown site.

Requirements

• Bachelor’s degree with a minimum of three years of experience in a regulated industry
• At least one year of experience developing, revising, or maintaining documentation within a GMP‑regulated environment.
• Proven ability to collaborate effectively across all organizational levels in a team‑oriented environment.
• Strong interpersonal skills with excellent verbal and written communication capabilities.
• Demonstrated technical writing skills and aptitude for translating complex requirements into clear, usable procedures.
• Self‑motivated with a strong track record of delivering commitments on time; exercises sound judgment and demonstrates strong investigative and analytical skills.
• Working knowledge of GMPs, applicable regulations, and governing compendia, including data integrity principles.

Nice To Haves

• FDA‑regulated or pharmaceutical experience preferred.
• General understanding of Manufacturing and Packaging processes within a regulated environment.
• General knowledge of GMP cleaning requirements and sanitation practices.
• Ability to create new SOPs and Supplements to support new equipment installations and Manufacturing and Packaging process changes.
• Experience reviewing Global SOPs, assessing impact to local procedures, and defining actions required to ensure ongoing compliance.

Responsibilities

• Serve as the Subject Matter Expert (SME) for SOPs and Supplements within OTC and Nutritional Manufacturing and Packaging departments.
• Provide specialized knowledge and technical support in quality assurance and control processes within the organization.
• Analyze quality data, develop best practices, and advise teams on compliance with industry standards and regulations.
• Collaborate with various departments to implement quality improvement initiatives and conduct training sessions.
• Ensure compliance, accuracy, standardization, and completeness of documentation supporting products manufactured and packaged at the Myerstown site, including OTC and Nutritional facilities.
• Support Bayer internal audits, Corporate Technical Audits, State GMP Health inspections, FDA, DEA, and foreign regulatory inspections, as required.
• Own the accuracy and cross‑functional review of IQMS documents.
• Manage periodic reviews of OTC and Nutritional Manufacturing and Packaging documents, including SOPs, Form Sheets, Supplements, and Standardized Documents.
• Collaborate regularly with cross‑functional leaders, SMEs, and site team members at all levels to gather input and feedback.
• Partner with the Compliance Support Specialist to investigate discrepancies and deviations in accordance with site policies and procedures, including root cause analysis and corrective actions.
• Review Global SOPs, assess impact to local procedures, and define actions required to maintain compliance.
• Apply a proactive, continuous improvement mindset to enhance Safety, Quality, Compliance, Efficiency, and procedural training across the site.
• Comply with all workplace standards, safety requirements, cGMPs, OSHA regulations, SOPs, and company guidelines.
• Support training development and training effectiveness; identify and evaluate future training needs and opportunities.

Benefits

• health care
• vision
• dental
• retirement
• PTO
• sick leave
• bonus or incentive compensation (if relevant)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees