• Quality Coordinator - Saxonburg, PA - STA

    Bayer (Saxonburg, PA)


    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.

     

    Quality Coordinator - Saxonburg, PA - STA

     

    Quality Coordinator – Saxonburg, PA - STA

     

    Purpose

     

    Provide Quality oversight for the issuance and reconciliation of manufacturing documentation and maintenance of these records to assure that a complete device history record is available. Review batch packets for sub-assembly, pre-sterile and post-sterile packaged product for release. Work cross-functionally to develop processes to support Product Release and track the efficiency and status of product release activities.

    Your tasks and responsibilities

    • Responsible for reviewing batch packet(s) for sub-assembly and pre-sterile packaged product for completion and adherence to requirements and specifications per associated DMRI and conducting required activities for record retention;

    • Reviews post-sterile packaged product for completion and adherence to requirements and specifications per associated DMRI and subsequent product release for distribution;

    • Required to work with site planning to prioritize creation and review of batch packets based on needs of the site and organization;

    • Communicates to applicable plant personnel for documentation being issued to support production operations. This includes, but is not limited to, batch packets, protocol documentation and non- conformance instructions;

    • Works with Sterility Assurance, Plant Quality and Manufacturing Engineering teams to develop processes and documentation to support Product Release and validations.

    • Function as back-up to Quality Coordinator or Training Coordinator

     

    Who you are

     

    Bayer seeks an incumbent who possesses the following

    REQUIRED QUALIFICATIONS

    • Associate's Degree preferred or 2 years of experience working in a medical device manufacturing facility;

    • Demonstrated proficiency in managing attention to detail;

    • Demonstrated proficiency in applying written and verbal communication skills, including interpersonal skills to proactively work with plant functions to facilitate deliverables;

    • Working knowledge and proven skills of PC computer system including Microsoft Office Applications (Outlook, Word, Excel, and PowerPoint);

    • This position requires a positive attitude and demonstrated willingness to support teamwork across plant support functions.

     

    Employees can expect to be paid a salary between $53,652.00 to $ 80,478.00. Additional compensation may include a bonus or incentive compensation (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc..

     

    This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

     

    This posting will be available for application until at least 12-1-2025

    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 Science for a better life, 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.

     

    Bayer is an E-Verify Employer.

     

    **Location:** United States : Pennsylvania : Saxonburg

    **Division:** Pharmaceuticals

    **Reference Code:** 855685

    Contact Us

    **Email:** [email protected]