This position is in the Quality Assurance department and the incumbent will be expected to continuously learn Quality Assurance systems, manufacturing, and effectively engage in relationships with peers in the laboratories, Manufacturing/Production and personnel in other departments as needed. Once the incumbent is assigned specific products on which to perform the quality assurance 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. The Drug Product testing team is responsible for Quality Control testing of over-the-counter pharmaceutical in process and finished packaged goods manufactured in Myerstown. In addition, the drug product testing team is also responsible for ensuring over the counter drug products within the stability program are tested according to the stability schedule and meet shelf-life specifications. This is a fast-paced, energetic team that works together to meet aggressive throughput times to support a lean manufacturing operation. Focus is on Finished Goods testing.
Position Summary:
Perform the analysis on intermediates, and finished products, following prescribed procedures to provide the information base leading to intermediates/product disposition. Assist in troubleshooting and problem solving as directed.
Position Duties and Responsibilities: • Perform standard qualitative and quantitative analysis on in-process products, pure drug substances and finished pharmaceutical preparations employing accepted gravimetric and spectrophotometer procedures, in accordance with approved testing procedures, the National Formulary (NF) and the United States Pharmacopoeia (USP). • Utilize standard "bench" chemistry technique as well as sophisticated electronic instrumentation, including HPLC, spectrophotometer, viscometer, etc. • Maintain records of all analysis information of assigned products on data sheets for permanent file 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 testing of in-process, finished Bulk products and Stability products to determine that the materials meet compendia and/or company standards. • Adhere to the pertinent aspects of Corporate and plant safety programs and adhering 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.
Skills & Competency Requirements: • Knowledge, practical application, and understanding of analytical chemistry is required 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. • Good working knowledge of advanced laboratory instrumentation and personal computer skills are 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. • Experience in wet analytical methods and instrumentation techniques preferred; HPLC, UV, GC, IR, and AA preferred.
Preferences:
- At least 1 year of lab experience preferred (outside of bachelor's degree), preferably in the pharmaceutical industry. A working knowledge of statistics, data processing and good manufacturing practices is desirable. 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 are preferred.