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Quality Analyst I

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 Analyst I

Quality Control

Perform the analysis on raw materials, intermediates, and finished products, following prescribed procedures to provide the information base leading to raw material/intermediates/product disposition. Assist in troubleshooting and problem solving as directed. If assigned to the Microbiology area, the focus is on micro testing.

YOUR TASKS AND RESPONSIBILITIES

+ Perform standard qualitative and quantitative analysis on purchased raw materials, in-process products, pure drug substances and finished pharmaceutical preparations employing accepted gravimetric and spectrophotometer procedures, in accordance with approved testing procedures of BAYER, the National Formulary (NF) and the United States Pharmacopoeia (USP).

+ Utilize standard "bench" chemistry techniques as well as sophisticated electronic instrumentation, including spectrophotometers, viscometers, etc.

+ Maintain records of all analysis of information of assigned products on data sheets for permanent files and proper entry of information on laboratory forms.

+ Evaluate all data obtained from analysis; if discrepancy or deviation occurs, consult with Supervisor and recommend additional testing if necessary.

+ 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 the pertinent aspects of Corporate and plant safety programs and adhere to GMP’s, ISO standards or other regulations.

+ Assist in investigating non-compliance investigations.

+ Assist with troubleshooting analytical methodology and instrumentation malfunctions.

+ Perform special assignments as directed by supervisor.

+ Assist in validation of manufacturing and production lines and equipment pertinent to chemistry and microbiology (e.g. equipment and room cleaning validation).

+ Perform testing of water samples from Purified (Deionized and Reverse Osmosis) Water, USP systems.

+ If assigned to Microbiology, perform microbiological environmental monitoring in production areas and in the Microbiology Laboratory.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

+ Bachelor's degree in chemistry, Biology, Pharmacy, or related 4-year science degree

+ Knowledge, practical application, and understanding of analytical chemistry is necessary to perform the functions of this position; Demonstrated capability for communicating ideas, concepts, and work results effectively to colleagues and supervision.

+ Demonstrated ability to be self-motivated as well as to work collaboratively in a team-based environment is required.

+ Must demonstrate initiative and a willingness to learn.

+ Personal computer skills are required.

+ If assigned to QC, good working knowledge of advanced laboratory instrumentation is required for QC area.

Preferred Qualifications:

+ If assigned to Microbiology area, microbiology experience and/or courses are preferred.

+ Experience in wet analytical methods and instrumentation techniques; HPLC, UV, GC, IR, AA, TOC, and Dissolution

+ A working knowledge of organic chemistry, statistics, data processing and good manufacturing practices

+ A 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

+ At least 1 year of lab experience preferred, however depending on area the following may be preferred: if assigned to the lab, bench chemistry or lab experience preferred.

+ If assigned to the QA Compliance area, previous experience in validation and QA auditing/release would be preferred; If MBR role, then automated inventory management and data collection experience is preferred (i.e. SAP skills, LIMs skills, DCS skills, etc.).

+ If assigned to Microbiology area, previous experience in microbiology processes would be preferred.

+ If assigned to Stability Administration a science degree with math curriculum is a plus and previous experience with laboratory computer information systems/database management systems is preferred, including knowledge of advanced laboratory instrumentation, analytical chemistry and organic chemistry is a plus.

+ If assigned to Metrology, previous experience with instrument repair, maintenance, and calibration experience is preferred.

+ If assigned to Methods Development, previous experience in method development, method validation, method transfers, instrument operation, calibration and maintenance is preferred.

+ If assigned to Quality Systems, experience with quality systems and data integrity projects is preferred.

Employees can expect to be paid a salary between $60,056.00 - $90,084.00. Additional compensation may include a bonus or incentive compensation (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. This salary range is merely an estimate and may vary based on an applicant's location, market data/ranges, an applicant's skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

This posting will be available for application until at least 11/4/2025.

\#LI-US

YOUR APPLICATION

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.

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.

Bayer is an E-Verify Employer.

**Location:** United States : Pennsylvania : Myerstown

**Division:** Consumer Health

**Reference Code:** 855083

Contact Us

**Email:** [email protected]