Senior Quality Control Analyst

Piramal Pharma • Bethlehem, PA

5d

About The Position

Perform testing on in-process material, bulk drug substance, finished drug product, and stability samples to support production, packing release, R&D, and regulatory filings. The Senior Quality Control Analyst also supports QC compliance, data integrity, electronic systems, audit and inspection readiness, laboratory investigations, and quality metrics. The role receives moderate to limited supervision, works from objectives set by a Manager, organizes and carries out most assignments according to standard practices, instructions, or prior training, and handles some situations independently.

Requirements

• Bachelor’s degree or Associate’s degree in science.
• At least 3 years of experience in a QC laboratory environment.
• Understanding of chemical processes and reactions.
• Awareness of cGMP, quality, and safety norms and requirements in a regulated industry.
• Ability to use logic and reasoning to assess alternative solutions, conclusions, or approaches to problems.
• Excellent customer service skills and professional demeanor when working with internal and external customers.
• Knowledge and practical understanding of electronic laboratory and computerized systems, including audit trails, electronic records, electronic signatures, user access, and system-generated data.
• Ability to organize and provide accurate laboratory documentation and supporting information for audits and inspections.
• Excellent verbal and written communication skills.
• Ability to present creative solutions.
• Energetic, enthusiastic, and motivational disposition; ability to maintain confidentiality and coach others.

Nice To Haves

• Prior experience with data integrity, electronic compliance, computerized laboratory systems, or serving as a quality or data integrity champion.
• Experience supporting internal, customer, or regulatory audits and inspections.
• Experience with quality metrics, laboratory performance monitoring, and trend analysis.
• Experience using SAP, Microsoft Office, Ensur, OpenLab, LabX, TrackWise, or CaliberLIMS.

Responsibilities

• Monitor and support QC compliance with electronic systems and computerized laboratory applications.
• Support periodic review of electronic records and audit trails.
• Support QC inspection and audit readiness; participate in internal, customer, and regulatory audits and inspections.
• Assist with preparing, reviewing, and submitting timely responses to audit observations and information requests.
• Serve as a QC Data Integrity and Compliance (DICO) Champion and promote data integrity, electronic compliance, and inspection readiness.
• Perform analytical testing of in-process material, bulk drug substance, finished drug product, stability samples, and raw materials.
• Sample, inspect, and test packaging components upon receipt.
• Document work according to cGMP and GDP, and maintain data integrity and regulatory compliance, including applying 21 CFR Part 11 requirements.
• Sample bulk API and bulk drums of API and raw material for QC analysis.
• Prepare quality metrics for in-process, API, and finished-goods turnaround times; interpret analytical data, identify trends, and communicate findings.
• Calibrate and perform minor troubleshooting on select laboratory instruments after appropriate training, including GC, HPLC, UV/Vis, IR, potentiometer, refractometer, Karl Fischer, density meter, and oven.
• Perform validation of new laboratory instruments and equipment as required.
• Perform daily laboratory duties, including balance checks, glassware washing, gas cylinder changes, temperature record checks, and inventorying supplies and reference standards.
• Assist other chemists with laboratory investigations into out-of-specification, out-of-trend, questionable results, and laboratory deviations.
• Manage and conduct assigned investigations for laboratory events, change controls, CAPA, and deviations.
• Oversee the training structure and train new hires as required.
• Peer review initial-analysis raw data to support timely material release.
• Assist the Lab Coordinator with stability sample put-ups or take-outs when necessary due to high sample volume.
• Assist the QC Supervisor with approval of stability packets in the required electronic system.
• Create or review QC-related documents as required.
• Follow company policies, procedures, and guidelines and conduct work in ways that protect employee and company interests and safety.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior