Compliance Support Documentation Specialist
Job
Bayer
Myerstown, PA (In Person)
$86,500 Salary, Full-Time
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Job Description
|
- Compliance Support Documentation Specialist | | | 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.
YOUR TASKS AND 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.
WHO YOU ARE
Bayer seeks an incumbent who possesses the following:Required Qualifications:
- 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.
Preferred Qualifications:
- 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. Employees can expect to be paid a salary between $69,200.00
- $103,800.
YOUR APPLICATION
| | Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Health for all, Hunger for none, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.To all recruitment agencies:
Bayer does not accept unsolicited third party resumes. Bayer is an Equal Opportunity Employer/Disabled/Veterans Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. |•Equal Opportunity Employer Statement:
Notice for U.S.Visitors:
All information on this site is subject to compliance with local rule and regulations as they may vary from time to time and across different geographies, including, without limitation, U.S. Executive Orders.| | Bayer is an E-Verify Employer.| | | |Location:
|United States :
Pennsylvania :
Myerstown |Division:
| Consumer Health |Reference Code:
| 866901 | |- Contact Us |
Email:
| hrop_usa@bayer.comSimilar jobs in Myerstown, PA
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