QUALITY CONTROL ANALYST – CHEMISTRY
Quality Control Analyst – Chemistry
Location: Myerstown, PA
Category: Scientific
Salary: Apply for details
Country: United States
Employment: Contract
Worksite: On-Site
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Job Description
Pay Range: $25-32/hr
• depending on experience
Job Title: Quality Control Analyst – Chemistry
Department/Team Description
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 of, 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 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.
Requirements/Preferences: Education Minimum Requirement Bachelors Degree
Skills & Competency Requirements
• At least 1 year of lab experience needed (outside of bachelors degree), preferably in the pharmaceutical industry.
• A working knowledge of statistics, data processing and good manufacturing practices is needed.
• 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.
Preference
A thorough understanding of National Formulary (NF); United States Pharmacopoeia (USP); and European Pharmacopoeia (EP) testing procedures, as well as, US Pharmaceutical Industry
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Staffing and Recruiting
Quality Assurance
Full-time