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 Control Co-op
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Quality Control Co-op, are to:
- Assist with vendor and site engineering for all facility changes (electrical, structural, water, etc.) necessary to support the installation of the new autoclave;
- Assist with Quality Systems department to create computerized System Design and Configuration (SCDS) and data integrity assessment documents;
- Perform any required computerized system User Acceptance Testing (UAT);
- Support vendor IQ/OQ activities;
- Support PQ vendor activities for the development and validation of autoclave cycles (heat penetration and distribution studies);
- Participate in activities which may include Biological Indicator (BI) incubation, interpretation of BI results, media preparation, media qualification testing, interpretation of cycle data and protocol review/development;
- Create Autoclave operation, maintenance, calibration, and security Standard Operating Procedures (SOPs);
- Create Media Control Records (MCRs) for media and equipment preparation, as applicable;
- Perform routine preparation of microbiology media per SOPs and as defined in media control records or protocols;
- Operate Autoclave for media, equipment, and lab waste sterilization;
- Operate MediaClave and MediaFill for media plate preparation and filing;
- Perform microbiological media qualification testing including growth promotion, sterility check, pH and inhibition testing as applicable;
- Maintain records of all tasks performed and data analysis on data sheets for permanent file;
- Maintain proper entry of information on laboratory forms and in laboratory notebooks;
- Evaluate all data obtained from analysis; if discrepancy or deviation occurs, consult with Supervision, and recommend additional testing if necessary;
- Assist with troubleshooting analytical methodology and instrument malfunctions;
- Adhere to the pertinent aspects of Corporate and plant safety programs;
- Adhere to GMPs, ISO standards or other regulations;
- Manage Biohazardous Waste for disposal method alternative during autoclave downtime;
- Develop/Revise LMS autoclave and media preparation curricula as appropriate.
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:
- Currently pursuing a minimum of a Bachelor’s degree in Chemistry, Biology, Pharmacy, Microbiology, Biochemistry or related field;
Be returning to school at the end of the co-op assignment to complete degree;
Able to commit to a 6-month (June – Dec.) assignment.
- At least one year of Microbiology lab experience and testing procedures;
- Working knowledge of Microbiology, statistics, data processing and good manufacturing practices;
- Thorough understanding of National Formulary (NF), United States Pharmacopoeia (USP), and European Pharmacopoeia (EP) testing procedures, as well as, US Pharmaceutical Industry Good Manufacturing Practices (GMP’s), quality control methods and procedures.
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.
Reference Code: 473965
Functional Area: Quality
Entry Level : Student