Quality Control Analyst - Microbiology/Stability Administration

Quality Control Analyst - Microbiology/Stability Administration (Contract) Myerstown, PA, United States (On-site) Contract (1 year) Job Summary We are seeking a detail‑oriented and motivated professional to join our Quality Assurance department in a fast‑paced, on‑site manufacturing environment supporting the production and packaging of OTC drug and nutritional products across multiple shifts. The incumbent will continuously develop expertise in Quality Assurance systems and manufacturing processes while building effective working relationships with peers across laboratories, manufacturing, and other departments. The position carries significant responsibility, as analytical results directly influence material disposition decisions, potential rejection of materials, and alterations to manufacturing procedures, schedules, or processes. The ideal candidate will bring strong microbiological knowledge, sound scientific judgment, and a commitment to compliance and quality standards. Responsibilities Perform standard qualitative and quantitative analysis on purchased raw materials, in‑process products, pure drug substances, and finished pharmaceutical preparations in accordance with approved testing procedures, including those of the National Formulary (NF) and the United States Pharmacopoeia (USP). Utilize standard bench microbiological aseptic techniques. Maintain accurate records of all analysis information for assigned products on data sheets and laboratory forms for permanent file. Evaluate all data obtained from analysis and consult with supervisor to recommend additional testing if discrepancies or deviations occur. Adhere to corporate and plant safety programs, GMPs, ISO standards, and other applicable regulations. Assist in investigating non‑compliance investigations and troubleshooting analytical methodology and instrumentation malfunctions. Assist in the validation of manufacturing and production lines and equipment pertinent to microbiology, including equipment and room cleaning validation. Prepare microbiological testing media and diluents. Perform testing of water samples from Purified (Reverse Osmosis) Water and USP systems. Perform microbiological environmental monitoring in production areas and in the Microbiology Laboratory. Review data and graphs for accuracy and trends. Manage samples by reconciling, acquiring, labeling, delivering, documenting, relocating, and discarding as appropriate. Perform special assignments as directed by supervisor. Skills Knowledge, practical application, and understanding of microbiology. Working knowledge of aseptic techniques, environmental monitoring methods, Gram staining, and microbiological test methods. Good documentation practices. Ability to work collaboratively in a team‑based environment. Analytical problem‑solving skills. Ability to work within established policies and procedures. Effective written and interpretive communication skills. Strong organization and planning skills. Working knowledge of statistics, data processing, and Good Manufacturing Practices (GMP) is desirable. Familiarity with National Formulary (NF), United States Pharmacopoeia (USP), and European Pharmacopoeia (EP) testing procedures preferred. General knowledge of stability programs preferred. Experience A minimum of 1 year of laboratory experience is required. Previous experience in microbiology processes or assignment within a microbiology area is preferred. Qualifications Bachelor’s Degree required, preferably in Microbiology, Biology, Chemistry, or a related scientific discipline. This is an exciting opportunity to join a dynamic and collaborative Quality Assurance team at a well‑established manufacturing facility, where your contributions will have a direct and meaningful impact on product quality and patient safety. You will have the opportunity to continuously grow your expertise in microbiological testing, regulatory compliance, and pharmaceutical manufacturing, all while working alongside experienced professionals in a role that offers both challenge and professional development. #J-18808-Ljbffr