Quality Control Analyst

Belcan - Myerstown, PA

Full-time - Entry Level

Myerstown, PA

Professional, Scientific, and Technical Services

About the position

The Quality Control Analyst position involves performing qualitative and quantitative analyses on pharmaceutical products to ensure compliance with industry standards. The role requires the use of advanced laboratory techniques and instrumentation, as well as maintaining accurate records of all analyses conducted. The analyst will also assist in troubleshooting and investigating non-compliance issues, contributing to the overall quality assurance processes within the organization.

Responsibilities

• Perform standard qualitative and quantitative analysis on in-process products, pure drug substances, and finished pharmaceutical preparations.
• Utilize standard bench chemistry techniques and sophisticated electronic instrumentation, including HPLC, spectrophotometer, and viscometer.
• Maintain records of all analysis information on data sheets for permanent file and proper entry on laboratory forms.
• Evaluate all data obtained from analysis and consult with Supervisor regarding discrepancies or deviations, recommending additional testing if necessary.
• Perform routine analytical testing of in-process, finished bulk products, and stability products to ensure compliance with compendia and company standards.
• Adhere to corporate and plant safety programs, GMPs, ISO standards, and other regulations.
• Assist in investigating non-compliance investigations.
• Assist with troubleshooting analytical methodology and instrumentation malfunctions.
• Perform special assignments as directed by supervisor.

Requirements

• Bachelor's Degree in a relevant field.
• Knowledge and practical application of analytical chemistry is required.
• Demonstrated capability for effective communication of ideas and work results.
• Ability to be self-motivated and work collaboratively in a team-based environment.
• Demonstrated initiative and willingness to learn.
• Good working knowledge of advanced laboratory instrumentation and personal computer skills.
• Competencies required include analytical problem solving, alertness, adherence to policies, commitment to tasks, decisiveness, effective written communication, and organization skills.
• Experience in wet analytical methods and instrumentation techniques preferred, including HPLC, UV, GC, IR, and AA.

Nice-to-haves

• At least 1 year of lab experience preferred, preferably in the pharmaceutical industry.
• Working knowledge of statistics, data processing, and good manufacturing practices is desirable.
• Thorough understanding of National Formulary (NF), United States Pharmacopoeia (USP), and European Pharmacopoeia (EP) testing procedures.
• Familiarity with Good Manufacturing Practices (GMPs) and quality control methods and procedures.