Bayer

QA 2 Microbiology-Part-Time

Employer
Bayer
Location
Myerstown, PA, United States
Posted
Jun 11, 2018
Ref
1SF22722
Required Education
Bachelors Degree
Position Type
Full time
Your tasks and responsibilities

The primary responsibilities of this role, QA 2 Microbiology, are to:

  • Perform standard qualitative and quantitative analysis on purchased raw materials, in-process products, pure drug substances and finished pharmaceutical/nutritional products in accordance with approved testing procedures of Bayer, the National Formulary (NF), United States Pharmacopoeia (USP), and the European Pharmacopoeia (EP);
  • Utilize standard analytical chemistry techniques including wet analytical methods as well as sophisticated electronic instrumentation (e.g., ICP, HPLC, UV, GC, IR, AA, CFA, TOC, dissolution apparatus and other automated instrumentation);
  • Function as safety team leader including training new analysts and qualify/approve reference standards;
  • Communicate to supervision in a timely manner all non-compliance situations and assist in investigations;
  • Maintain complete and accurate records of all analytical information according to Bayer and regulatory standards;
  • Evaluate all data obtained from analysis to ensure that all Bayer and regulatory specifications are met;
  • Perform routine analytical and microbiological testing of raw materials purchased from prospective suppliers to determine that the materials meet compendia and/or company standards;
  • Adhere to all aspects of Corporate and plant safety programs, GMP's, ISO standards or other regulatory requirements;
  • Distribute and retrieve stability samples from storage and schedule samples for testing;
  • Conduct Laboratory information management System (LIMS) approval of completed stability samples;
  • Review stability data for compliance and initiate stability of new studies or focus may be in Quality Systems and data integrity projects;
  • Revise existing analytical testing monographs to comply with compendia changes or other specific needs;
  • Assist in validation of manufacturing and production lines and equipment pertinent to chemistry and microbiology (e.g. equipment and room cleaning validation);
  • Perform microbiological environmental monitoring in production areas and in the Microbiology Laboratory;
  • Prepare new monographs in conjunction with R&D for new products/components;
  • Retrieve analytical test results and summarize for annual product reviews;


Who you are

  • Ability to work minimum 20 hours per week.


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 related science degree with at least three years of experience in a GMP laboratory environment; or
  • Master's degree in a related field with zero years of relevant experience may be considered;
  • Basic experience with a Personal Computer (PC);
  • Possess knowledge, practical application and understanding of analytical chemistry to perform the functions of this position;
  • Good working knowledge of advanced laboratory instrumentation and computers;
  • Strong troubleshooting skills for assigned area such as HPLC, GC, AA, UV, TOC, NIR and/or dissolution and low error rates with microbiology or chemistry techniques for defined area;
  • Working knowledge of aseptic techniques, environment monitoring methods, Gram staining and microbiological test methods would be equivalent experience;
  • Demonstrated ability to clearly communicate technical information in writing;
  • Demonstrated capability for communicating ideas, concepts, and work results effectively to colleagues and supervision, who have various degrees of technical understanding;
  • Demonstrated ability to manage key projects and display area of expertise (i.e., clear/consistent notebook skills and function as an independent worker);
  • 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 analytical problem solving, alertness, work within established policies and procedures, commitment to task, decisiveness, effective written and interpretive communication skills, and organization and planning skills.

Preferred Qualifications:

  • Experience using Microsoft office software and LIMS;
  • Experience in wet analytical methods and instrumentation techniques such as HPLC, UV, GC, IR, AA, TOC, and Dissolution;
  • Working knowledge of organic chemistry, statistics, data processing and good manufacturing practices;
  • Possess 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.


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