Quality Analyst III, Bulk - 2nd Shift:
Bayer AG

Bayer AG
Myerstown Penn
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. 


Quality Analyst III, Bulk - 2nd Shift 




The primary responsibilities of this role, Quality Analyst III, Bulk - 2nd Shift, are to: 


  • Be responsible for overseeing bulk, in-process, and stability testing performed on 2nd shift to support site operations. Provide technical/analytical support for testing operations. 
  • Support PrT in experimental and validation activities by assisting with testing, when necessary; 
  • Perform standard qualitative and quantitative analysis on: purchased raw materials, in-process products, pure drug substances and finished pharmaceutical preparations in accordance with approved testing procedures of Bayer, the National Formulary (NF), United States Pharmacopoeia (USP), and the European Pharmacopoeia (EP);
  • Prepare written technical documentation defining the operation, calibration and maintenance of typical laboratory instrumentation;
  • Perform statistical analysis of laboratory data using general laboratory statistics;
  • Incumbent will be expected to develop critical judgment quickly in this position, as disposition decisions immediately affect production schedules;
  • Utilize standard analytical chemistry techniques including wet analytical methods as well as sophisticated electronic instrumentation (HPLC, UV, GC, IR, AA, TOC, dissolution and other automated instrumentation);
  • Provide support for investigations of production non-compliance situations to determine course of action for packaging components, bulk & finished products;
  • Responsible for conducting OOS and other laboratory investigations for 2nd Shift, but may also be involved with 1st Shift investigations.  Prepare subsequent reports, memos and provide follow up training and documentation for corrective actions;
  • Troubleshoot and resolve analytical methodology and instrumentation malfunctions;
  • Maintain complete and accurate records of all analytical information according to Bayer and regulatory standards;
  • Adhere to all aspects of Corporate and plant safety programs, GMP’s, ISO standards or other regulatory requirements;
  • Perform review and approval of SAP QM master and local data;
  • Responsible for training new analysts;
  • Function as team leader on 2nd Shift;
  • Prepare technical reports on assigned products, processes and prepare qualification plans;
  • Adjust work schedule to support off shift hours for QA support as needed;
  • Perform other duties and special assignments as directed by QC manager.




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, or science with at least  four (4) years of experience in a GMP laboratory environment;
  • Excellent written and communication skills - Demonstrated ability to clearly communicate technical information ideas, concepts and work results verbally and in writing to colleagues, supervisors and representatives of other companies who may have varying degrees of technical understanding;
  • Demonstrated ability to be self-motivated as well as to work collaboratively in a team-based environment;
  • Demonstrated ability to take initiative and display a willingness to learn;
  • Flexibility to support 2nd, 3rd shifts and weekends for QA support as needed;
  • Demonstrated ability to quickly adjust to changing production and project requirements;
  • Demonstrated ability to think creatively and determine method development steps without supervision;
  • Demonstrated ability to deal with project failures on a routine basis in a professional and positive manner;
  • Demonstrated ability to lead others - i.e. "go to" person in absence of supervisor, decision making at higher level than a QA2 level, strong/good communication to management;
  • Must be able to occasionally travel to other Bayer sites or other companies as needed to support business;
  • Strong HPLC and computer skills, including excel spreadsheet and HPLC software;  
  • Strong knowledge of pharmaceutical product testing & solid understanding of general laboratory statistics;
  • Demonstrated ability to write technical documents in support of method development, method validation, method transfers, instrument operation, calibration and maintenance;
  • Knowledge, practical application and understanding of analytical chemistry and instrumental analysis are necessary to perform the functions of this position.  Good working knowledge of wet analytical chemistry and advanced laboratory instrumentatio (including HPLC, UV, GC, IR, AA, TOC and Dissolution); A thorough understanding of National Formulary (NF); United States Pharmacopeia (USP); and European Pharmacopeia (EP) testing procedures, as well as, US Pharmaceutical Industry Good Manufacturing Practices (GMP’s), quality control methods and procedures.



Preferred Qualifications:


  • Experience using Microsoft office software and SAP.





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:16102   
Contact Us
+ 1 888-473-1001, option #5
Basic Qualifications