Quality Analyst II (Stability Administration) - 1st Shift
Location:
Myerstown , Pennsylvania
Posted:
November 23, 2017
Reference:
465802450
Your tasks and responsibilities
The primary responsibilities of this role, Quality Analyst II (Stability Administration) 1st Shift, are to:

  • Initiate and review new Stability studies in SAP QM;
  • Distribute and retrieve stability samples from storage;
  • Prepare written technical documentations related to stability including SOP's, protocols, summary reports, risk assessment, Stability Incident Notices, Out of Specification (OOS) Investigations, LMS modules, and justification memos;
  • Prepare and review annual product reviews, stability trends and NDA reports;
  • Evaluate all data obtained to ensure that all Bayer and regulatory specifications are met;
  • Evaluate laboratory data for adverse trends and compile in various reports;
  • Perform statistical analysis of laboratory data using general laboratory statistics;
  • Conducting OOS and other laboratory investigations. Prepare subsequent reports, memos and provide follow up training and documentation for corrective actions;
  • Coordinate testing to ensure testing deadlines are met;
  • Collaborate within the QC department and with other departments as necessary;
  • Attend project meetings;
  • Provide technical advice and expertise to laboratory analysts;
  • Communicate stability results to management and project teams;
  • Compile KPI information;
  • Maintain complete and accurate records according to Bayer and regulatory standards;
  • Conduct SAP-QM approvals of completed stability samples;
  • Train new analysts;
  • 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) utilizing 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) to meet manufacturing or Stability testing schedules, as required;
  • Function as team leader as required;
  • Balance conflicting priorities and deadlines;
  • Adjust work schedule to provide QA and Manufacturing support as required;
  • Adhere to all aspects of Corporate and plant safety programs, GMP's, ISO standards or other regulatory requirements;
  • Perform other duties and special assignments as directed by QC supervisor.


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 or Science with at least (3) three years of testing experience in a GMP laboratory environment or a Master's degree in a related field with (0) zero years experience;
  • Knowledge, practical application and understanding of analytical chemistry and instrumental analysis are necessary to perform the functions of this position. Good working knowledge of pharmaceutical wet analytical chemistry and advanced laboratory instrumentation required (including HPLC, UV, GC, IR, AA, and Dissolution);
  • Basic experience with Personal Computer (PC) required;
  • 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), and quality control methods and procedures;
  • Strong understanding of general laboratory statistics;
  • 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;
  • Demonstrated ability to be assertive and creative in managing his/her own workload with sometimes conflicting priorities and deadlines;
  • Demonstrated ability to deal with project failures on a routine basis in a professional and positive manner;
  • Demonstrated ability to lead others;
  • Demonstrated ability to write accurate and complete technical documents;
  • Demonstrated ability to meet customer needs;
  • Demonstrated ability to manage key projects and display areas of expertise;
  • Must be able to occasionally travel to other Bayer sites or other companies.
Preferred Qualifications:

  • Experience administrating a stability program;
  • Experience testing Drug and Nutritional products;
  • Computer programming skills using MS Excel and Access;
  • Experience using Microsoft office software, SAP-QM, SAP-QM Stability module, and B23;
  • Bachelors of Science in Chemistry.

#KRT

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. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. 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.
 

Country: United States
Location: PA-Myerstown

A little about us:
Why Bayer? Because we’re a pioneer in the fields of human, animal, and plant health. Because we invent solutions that will create a sustainable future for our planet. Because a career with Bayer means you can put your passion into practice and make an impact.

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