What are the responsibilities and job description for the Quality Control Analyst position at Piramal Pharma Solutions?
Business: Critical Care
Department: Quality Control
Location: Bethlehem
Job Overview
Perform testing on in-process material, bulk drug substance, finished drug product, and stabilities in support of production, packing release, R&D and regulatory filings.
Key Stakeholders: Internal
Cross Functional teams in Plant, Teamwork
Key Stakeholders: External
Auditor
Reporting Structure
Reports to Quality Control Lab Supervisor
Essential Duties and Responsibilities
- Perform analytical testing and release of in-process material, bulk drug substance, finished drug product, and stability sample
- Sampling, inspection and testing of raw materials and packaging components upon receipt
- This includes proper documentation of all work according to cGMP
- Responsible for Sampling of Bulk API and Bulk drums (API and Raw material) for analysis by QC
- Perform Calibration and minor troubleshooting on select laboratory equipment including GC, UV/Vis, IR, Potentiometer, Refractometer, Karl Fischer, Density meter and ICP/MS (with appropriate training)
- Perform minor maintenance on GC equipment when necessary
- Perform daily general duties in a proper functioning QC lab like: Balance checks, glassware washing, gas cylinder changes, temperature record checks, verify inventory supplies etc
- Assist other chemists in completing quality laboratory investigations in response to out of specification, apparent failure or questionable results or in response to a lab deviation
- Peer Review of raw data of initial analyst in order to release material in a timely fashion
- Assist Lab Coordinator with Stability put-ups or take-outs when necessary due to large volume of samples
Key Competencies (knowledge, skills and abilities every person must possess to be successful)
- Critical Thinking — using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems
- Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers
- Excellent verbal and written communication skills
- Creative and able to present various solutions
- Energetic, enthusiastic and motivational disposition
- Maintain confidentiality
- Coaching skills
Education / Experience
- Bachelor’s Degree in Science or Associates Degree
- 3 plus years of experience
- Understand chemical processes and reactions
- Awareness on cGMP, quality and safety norms and requirements
- Usage of technology tools such as SAP, MS office, Ensur, Openlab, LabX
