400 West Stoever Avenue Myerstown Pennsylvania USA 17067 Myerstown, PA 17067 US
Target Pay Rate: 20-29.13/hr **salary will be commensurate with experience
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.
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 on: purchased raw materials and pure drug substances employing accepted gravimetric and spectrophotometer procedures, in accordance with approved testing procedures, including those from client, the National Formulary (NF) and the United States Pharmacopoeia (USP).
- Utilize standard "bench" chemistry technique as well as sophisticated electronic instrumentation, including spectrophotometer, viscometer, etc.
- Maintain records of all analysis information of assigned materials on data sheets for permanent file and proper entry of information in laboratory notebooks.
- 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 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 adhering to GMPs, 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.
- Bachelors degree in Chemistry, Biology, Pharmacy, or related 4 year science degree required. Chemistry degree is preferred.
- At least 1 year of lab experience required (outside of bachelors degree), preferably in pharmaceutical or nutritional industry.
- 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 required; HPLC, UV, GC, IR, and AA preferred.
- 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 (GMPs), quality control methods and procedures preferred.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.