Senior Quality Control Analyst

Piramal Pharma Ltd•Bethlehem, PA

18h

About The Position

The Senior Quality Control Analyst performs testing on in-process material, bulk drug substance, finished drug product, raw materials, packaging components, and stability samples in support of production, packing release, research and development, and regulatory filings. The role supports QC compliance with electronic systems and computerized laboratory applications, data integrity, audit readiness, and regulatory requirements. The analyst works with moderate to limited supervision, organizes and carries out assignments using standard practices and training, and handles some situations independently. The position also performs laboratory instrument calibration, troubleshooting, and validation; supports laboratory investigations, change controls, CAPA, and deviations; prepares quality metrics and reviews analytical data; and assists with training, stability sample activities, documentation, and timely material release. The analyst is expected to follow company policies and procedures and protect the interests and safety of employees and the company.

Requirements

Bachelor’s degree or Associate’s degree in science.
At least 3 years of experience in a QC laboratory environment.
Understand chemical processes and reactions.
Awareness of cGMP, quality, and safety norms and requirements in a regulated industry.
Understand and apply 21 CFR Part 11 requirements.
Knowledge and practical understanding of electronic laboratory and computerized systems, including audit trails, electronic records, electronic signatures, user access, and system-generated data.
Excellent verbal and written communication skills.
Critical thinking skills, including using logic and reasoning to assess alternative solutions, conclusions, or approaches.
Excellent customer service skills and professional demeanor when interfacing with internal and external customers.
Ability to organize accurate laboratory documentation and supporting information for audits and inspections.
Ability to prepare quality metrics and communicate analytical findings.
Ability to present different solutions, maintain confidentiality, and provide coaching.

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 using technology tools such as SAP, MS Office, Ensur, OpenLab, LabX, TrackWise, or CaliberLIMS.
Experience with quality metrics, laboratory performance monitoring, and trend analysis.

Responsibilities

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.
Sample bulk API and bulk drums containing API and raw material for QC analysis.
Document all work according to cGMP and GDP.
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 activities; participate in internal, customer, and regulatory audits and inspections.
Assist with preparation, review, and timely submission of 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.
Prepare quality metrics for in-process, API, and finished-goods turnaround times.
Perform calibration and 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 routine QC laboratory duties, including balance checks, glassware washing, gas cylinder changes, temperature record checks, and inventorying supplies and reference standards.
Assist chemists with quality laboratory investigations involving out-of-specification, out-of-trend, questionable results, or laboratory deviations.
Manage and conduct investigations, as assigned, for laboratory events, change controls, CAPA, and deviations.
Oversee the training structure and train new hires as required.
Peer-review raw data from initial analyses to support timely material release.
Assist the Lab Coordinator with stability sample put-ups or take-outs when needed 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.
Interpret analytical data, identify trends, and communicate findings effectively.
Maintain confidentiality and follow company policies, procedures, and guidelines.