QA 4: Compliance

Bayer Inc. Myerstown , PA 17067

Posted 2 months ago

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

QA 4: Compliance

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Quality Assurance 4, are to:

  • Oversee the sampling, testing, and releasing of components for specified area (i.e. packaging, raw materials, microbiology testing, etc.) to ensure a timely release to meet production requirements;

  • Ensure that drug products are manufactured to meet monograph specifications/ Certified Good Manufacturing Practices (CGMP);

  • Be responsible for determining the accuracy, sensitivity, specificity, and reproducibility of specific area/analytical test methods to ensure that established specifications are met;

  • Lead Quality Assurance (QA) teams in specified area to ensure that testing, evaluating, documenting, and releasing (i.e. raw materials, in-process bulk products, or finished products) to meet established specifications;

  • Investigate non-compliance situations to determine a course of action for status (i.e. packaging components, raw materials, bulk products, or finished products), and work toward a timely resolution, and communicate to appropriate production personnel;

  • Be responsible for auditing of manufacturing/packaging areas/operations to ensure compliance with CGMP/Bayer policies;

  • Be responsible for maintenance and approval of expiration dating, assignment of control numbers and batch numbers;

  • Lead analytical and microbiological method validation program to ensure analytical testing procedures comply with United States Pharmacopoeia (USP), National Formulary (NF), regulatory parameters and in-house procedures;

  • Be responsible for developing new analytical and microbiological testing methodologies, and/or improving existing test methods to increase laboratory efficiency and analytical reliability;

  • Coordinate update of approved documentation with update of LIMS and actual implementation of revised test methods;

  • Communicate proposed compendia changes to management and potential effect on products controlled by the Myerstown, PA site, may perform similar tasks for regional products as needed;

  • Revise existing analytical testing monographs to comply with compendia changes or other specific needs;

  • Prepare new monographs in conjunction with Research and Development for new products/components;

  • External Auditor and Consumer Complaint management;

  • Perform other duties as assigned.

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

  • Bachelor's degree in Chemistry, Biology, Pharmacy, Microbiology or related science with at least 6 years of QA experience;

  • Demonstrate leadership experience, including strong business acumen and understanding of GMPs/Pharmaceutical standards;

  • Knowledge, practical application and understanding of the sciences are necessary to perform the functions of this position, as well as scheduling, follow-up, and problem-solving skills;

  • A working knowledge of CGMPs and Bayer pharmaceutical standards;

  • Demonstrate ability to work in a team-oriented environment and good communication skills;

  • Demonstrate ability to take initiative and a willingness to learn and stay abreast of current standards;

  • Be self-motivated and expected to develop critical judgments in this position, as disposition decisions affect production schedules and products getting to the marketplace;

  • Demonstrate ability to meet customer needs;

  • Personal computer skills;

Preferred Qualifications:

  • At least 2 years supervisory experience as part of 6 years QA experience;

  • If hiring focus is for Microbiology Lab;

  • Vitamin testing experience, i.e. Biotin Assays or B12 Assays, as well as demonstrated ability to test and analyze microbiological pharmaceutical requirements.

YOUR APPLICATION

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. 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. Location: United States : Pennsylvania : Myerstown Division: Consumer Health Reference Code: 166543 Contact Us + 1 888-473-1001, option #5

Job Segment: Compliance, Microbiology, Agricultural, Law, Pharmacy, Legal, Science, Agriculture, Healthcare


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QA 4: Compliance

Bayer Inc.