Quality Control Analyst II

QC Analyst II, 2nd shift

Department: Quality Location: Sellersville, PA

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. www.piramalpharmasolutions.com

The QC Analyst II performs microbiological examination testing on raw materials, finished products, environmental monitoring (air, water, surface) and stability samples in accordance with approved Standard Operating Procedures (SOPs) or USP methods, where applicable.

Responsibilities

• Physical testing, chemical, or microbiological analysis of raw materials, finished products, stability and special samples
• Documenting and submitting all raw data and results in LIMS
• Preparation of reagents for chemical analysis
• Microbiological media growth promotion
• Data auditing for lot disposition
• Method verification, validation and technology transfer for new products

Experience

• Bachelor's degree in chemistry, biology, or other related science with relevant laboratory coursework is required
• Strong written, verbal, and interpersonal communication skills
• Proficiency with Microsoft Office
• Working knowledge of basic microbiological or analytical chemistry testing
• Experience with LIMS or similar data management software
• Minimum 5 year's experience, preferably in a GMP environment