Job Description

TITLE: QUALITY CONTROL CHEMIST- 2ND SHIFT DURATION: 12 MONTHS LOCATION: MYERSTOWN, PA 17067    DESCRIPTION: The Raw Material testing team is responsible for Quality Control testing of APIs and excipients used in the manufacture of pharmaceutical and nutritional products. This is a fast-paced, energetic team that works together across two shifts to meet aggressive throughput times to support a lean manufacturing operation. POSITION SUMMARY: In this position, the incumbent will be expected to draw upon previous analytical experience, as well as continuously learn Quality Control systems and effectively engage in relationships with peers in the laboratories, Manufacturing/Production, and personnel in other departments as needed. The incumbent will perform analysis on raw materials following prescribed procedures to provide the information base leading to material disposition, as well as assist in troubleshooting and problem solving as directed. Once the incumbent is assigned specific materials on which to perform the quality control tests, or provide development or troubleshooting, the incumbent will have considerable impact on results from his/her work. Material can be rejected and manufacturing procedures can be altered significantly either in schedule changes or in process itself. POSITION DUTIES & RESPONSIBILITIES : Perform standard qualitative and quantitative analysis: • Utilize standard analytical chemistry techniques: wet analytical methods, HPLC, UV, GC, AA, polarimeter, FT-IR, NIR, RAMAN, etc.) to test raw materials in accordance with approved testing procedures, including those from company, the National Formulary (NF), the United States Pharmacopoeia (USP), the European Pharmacopoeia (EP), and the FDA. • Properly document and maintain records of all analysis information of assigned materials on data sheets and laboratory notebooks for permanent file. • Evaluate all data obtained from analysis; if discrepancy or deviation occurs, consult with Supervisor and recommend additional testing if necessary. • Communicate to supervision in a timely manner all non-compliance situations, and assist in investigations. • Assist with troubleshooting analytical methodology and instrumentation malfunctions. • Perform special assignments as directed by supervisor, for example, revise existing analytical testing monographs to comply with compendia changes or other specific needs. • Accurate, complete and timely fulfillment of the job responsibilities will, in part, ensure GMP compliance as outlined in various Bayer and U.S. government rules and regulations. Documentation Review: • Review testing documentation performed by other analysts for compliance with BAYER, FDA, National Formulary (NF), United States Pharmacopoeia (USP), and European Pharmacopoeia (EP) procedures. Safety: • Adhere to the pertinent aspects of Corporate and plant safety programs and adhering to GMP’s, ISO standards or other regulations.  

Qualifications

REQUIREMENTS/PREFERENCES: • Bachelor’s degree in Chemistry, Biology, Pharmacy, or related 4 year science degree required. Chemistry degree is preferred. • At least 1-3 years of experience in a GMP laboratory environment. Master’s degree in a related field with 1 year of experience may be considered. • Knowledge, practical application, and understanding of analytical chemistry is required to perform the functions of this position. • Basic experience with Personal Computer (PC). • 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. • Good working knowledge of advanced laboratory instrumentation and personal computer skills are required. • Good working knowledge of advanced laboratory instrumentation and computers are required; This is defined as 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 • A working knowledge of organic chemistry, statistics, data processing and good manufacturing practices is required • Demonstrated ability to clearly communicate technical information in writing required. • 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 is required. • Demonstrated ability to take initiative and display a willingness to learn required. • 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 is required. • Competencies required: 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. • Enter here Travel Requirements: None   THANKS & REGARDS, MAYANK GUPTA, (M. PHARMACY) (LEAD PHARMA TECHNICAL RECRUITER)  

Additional Information

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