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.

Analyst III QC Protein Characterization

Your tasks and responsibilities

The primary responsibilities of this role, Analyst III QC Protein Characterization, are to: 

 

 • Perform analytical testing to support the release, stability, and in
 process testing samples, or final products and supports the release of
 materials for production or products for commercial use.
 • Accurately follows relevant SOPs, performs all activities in
 accordance with cGMP requirements, and reports abnormalities.  Initiates and
 completes laboratory discrepancy events on time.
 • Document test results to ensure completeness and accuracy per cGMPs.
 Keeps accurate documentation and tracks record. Compiles, enters and
 reviews data into LIMS or other databases/Excel sheets.  Evaluates
 data/interprets trends.
 • Demonstrate hands-on knowledge of operating, maintenance and
 troubleshooting skills forHPLC instruments as well as quality and
 regulatory requirements pertinent to quality control labs.  Performs
 moderate to complex equipment troubleshooting. Performs laboratory
 cleaning/maintenance activities.
 • Contribute toward the development, revision, application,
 maintenance, validation and review of quality systems, drafting SOPs,
 and methods for processing and/or ensuring quality in raw materials,
 intermediates, or finished products.
 • Support department improvement projects related to release goals, the
 identification of root cause for investigations, and the improvement of
 laboratory test methods.  Performs Discrepancy Management
 investigations, writes/reviews laboratory investigation reports and
 implements corrective and preventative actions.
 • Perform assay training, manages multiple tasks concurrently and
 effectively.  Assist and troubleshoot with assay performance.   Perform
 non-routine laboratory tasks.
 • Gather information necessary to support changes to existing methods
 according to approved procedures. Initiates Change Control requests in
 Bayer's document management system and follows through until the
 completion of workflows
 • Contribute toward the development, revision, application,
 maintenance, validation and review of quality standards, drafting SOPs
 • Assist with addressing questions during regulatory compliance audits
 and supports inspection-related needs as required.
 

 

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:

 

  •  BS/BA degree in a scientific discipline or equivalent education/training
  •  5 years of experience performing relevant activities including working  in a cGMP compliant environment required; thorough understanding of manufacturing process records content or manufacturing process records
  • Experience with a cGMP and global regulatory compliance organization is required
  • Experience with protein, carbohydrate, small molecule and excipient testing of Chromatography techniques are required
  • Experience with chromatography systems and software (Waters/Empower, Dionex/Chromelean, Agilent/Chemstation, AKTA/Unicorn) is required
  • Experience with Wet-Chemical techniques, Spectroscopy is desired
  • Ability to multi-task and good adaptability to changing business requirements in a dynamic corporate environment.
  • Familiarity with Bayer products and manufacturing processes highly desirable
  • Strong computer and communication skills are required
  • Experience with equipment and analytical method validation laboratory execution is required
  • Strong technical writing skills for reports and SOPs are equired.
  • Familiarity with LIMS and SAP systems is desired.
  • Familiarity with JMP
  • Focus on Goals
  • Focus on the Customer
  • Continuously Improve
  • Integrity and Commitment to Company Beliefs and Values

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: CA-Berkeley
Functional Area: [sap_fa_20]
Entry Level: 3