Quality Control Environmental Monitoring Analyst III

 

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

 

Quality Control Environmental Monitoring Analyst III 

 

Union Position that performs routine and non-routine environmental monitoring, microbiological testing of commercial and Bio-Development manufacturing. Performs non-routine support for validation, facility or utility maintenance, and other projects as directed by a supervisor or designate.

 

YOUR TASKS AND RESPONSIBILITIES

Shift Friday-Monday 8am-6:30pm 

 

The primary responsibilities of this role, Quality Control Environmental Monitoring Analyst III, are to:

• Follows standard operating procedures to perform routine environmental monitoring of manufacturing facilities, laboratory and utility systems at the Berkeley site.
• Perform non-routine testing to support validations, performance qualifications, maintenance/repairs, sample receipt and projects as directed by a supervisor or designate.
• Follows all good manufacturing practices and good laboratory practices, safety rules and department guidelines. Uses care and judgement in the use and handling of laboratory materials and equipment to maintain a compliant, safe, clean and orderly working environment.
• Perform documentation and other duties according to cGMP rules and regulations using test records, logbooks, or computer systems. Maintains laboratory inventory.
• Actively participate in relevant site initiatives such as: Behavior Based Safety (BBS) and Product Supply System (PSS).
• Maintain current training status for assigned SOPs, SOP revision training, GMP and HSES training. Maintain minimum eighty-five percent (85%) qualification in Curriculum.
• Performs 5S and safety audits of lab area and maintains lab in a compliant state.
• Perform other duties as assigned.
• Perform routine calibration of lab instruments and clean lab equipment
• Peer review of test results may be required.
• Receive and log samples in MODA or LIMS.

 

WHO YOU ARE                                        

 

Bayer seeks an incumbent who possesses the following:

 

Required Qualifications:

• Requires Associate degree in Biological Sciences or an equivalent combination of education and experience. Aseptic technique and attention to detail is essential. Familiarity with a pharmaceutical, clinical or quality working environment is desirable.

• Working knowledge and understanding of cGMP and global regulatory compliance.
• Experience and competency with USP, EP, JP, ACS, FCC compendia/monographs.
• Experience working in a Quality Control environment

 

Additional Requirements:

• Read, write, speak, and comprehend English in order to understand and follow written and verbal instructions, SOP’s, etc.
• Acceptable attendance and performance.
• Work weekends, holidays and overtime as required.
• Strong interpersonal skills with the ability to work effectively as part of a team.
• Work independently and self-directed with minimal supervision.
• Detail oriented with the ability to demonstrate good record keeping practices and ability to follow data integrity rules.
• Ability to multitask, troubleshoot, use analytical judgment to plan and perform diversified work, making decisions within prescribed limitations, and good adaptability to changing business requirements in a dynamic corporate environment.
• Work safely in an environment containing hazardous chemicals, high and low temperature liquids, high pressure liquids and gasses, steam, and moving machinery.
• Strong computer skills required.
• Familiarities with Lab management systems (LIMS) and Mobile Data Acquisition System (MODA).
• SAP (or similar software) strongly preferred.
• Follow directions, written or verbal
• Follow Standard Operating Procedures (SOPs).
• Working knowledge of cGMP and global regulatory compliance.

 

Physical Qualifications:

• Must be able to lift up to ≤25 lbs. and push/pull up to ≤650 lbs. with assistance.