Senior Quality Control Analyst

piramalpharma; Town of Bethlehem (NY); On-site; USD 85,000 - 110,000; Full time

Job summary

Piramal Critical Care (PCC) is seeking a Senior Quality Control Analyst to perform testing on in-process materials, bulk drug substances, and finished drug products, while ensuring CGMP/GDP compliance. The role supports electronic systems, audit trails, and inspection readiness across QA functions.

The ideal candidate has 3+ years of QC experience in pharma, strong data integrity skills, and familiarity with regulatory expectations, contributing to timely audit responses and continuous

Qualifications

• Bachelor's or Associate degree in science required.
• 3+ years of QC experience in pharma or related field.
• Strong attention to data integrity and regulatory compliance.

Responsibilities

• Perform testing on in-process material, bulk drug substance, finished drug product, and stabilities.
• Monitor and support QC compliance with electronic systems and computerized laboratory applications.
• Support periodic review of electronic records and audit trails.
• Support inspection and audit readiness activities within QC.
• Participate in internal, customer, and regulatory audits/inspections.
• Assist in preparing responses to audit observations and information requests.
• Serve as a QC Data Integrity and Compliance (DICO) Champion.
• Perform analytical testing and sampling of materials.
• Maintain proper documentation according to cGMP and GDP.
• Understand 21 CFR Part 11 requirements.

Skills

Critical thinking

Customer service

Data integrity

Analytical data

Electronic lab systems

Audit readiness

Communication skills

Data interpretation

Education

Bachelor's degree in science

Associate's degree in science

Tools

GC

HPLC

UV/Vis

IR

Potentiometer

Refractometer

Karl Fischer

Density meter

Oven

Job description

Division

Piramal Critical Care Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders. PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has a strong manufacturing and process development experience with wholly‑owned, state‑of‑the‑art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high‑quality products around the world, timely at optimal costs.

Job Title

Senior Quality Control Analyst

Job Description

• 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.


• Monitor and support QC compliance with electronic systems and computerized laboratory applications.


• Support periodic review of electronic records and audit trails.


• Support inspection and audit readiness activities within QC.


• Participate in internal, customer, and regulatory audits/inspections.


• Assist in the preparation, review, and timely submission of responses to audit observations and requests for information.


• Serve as a QC Data Integrity and Compliance (DICO) Champion.


• Perform analytical testing of in-process material, bulk drug substance, finished drug product, stability samples, and raw materials.


• Sampling, inspection and testing of packaging components upon receipt.


• Proper documentation of all work according to cGMP and GDP.


• Understand and apply the 21 CFR Part 11 requirements.


• Maintains data integrity and compliance with regulatory standards.


• Responsible for sampling of bulk API and bulk drums (API and raw material) for analysis by QC.


• Prepare Quality Metrics for in-process, API, and FG turnaround times.


• Perform calibration and minor troubleshooting on select laboratory instruments with appropriate training including GC, HPLC, UV/Vis, IR, Potentiometer, Refractometer, Karl Fischer, Density meter, Oven.


• Perform validation of new lab instruments and equipment as required.


• Perform daily general duties in a proper functioning QC lab like balance checks, glassware washing, gas cylinder changes, temperature record checks, inventory supplies including reference standards.


• Assist other chemists in completing quality laboratory investigations in response to out of specification, out of trend, questionable results or in response to a lab deviation.


• Manage and conduct investigations, as assigned and required, for laboratory events, change controls, CAPA, and deviations.


• Oversee the training structure and conduct training for new hires as required.


• Peer review of raw data of initial analysis 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.


• Assist QC Supervisor in the approval of stability packets in the required electronic system.


• Able to create or review QC related documents as required.

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.


• Ability to serve as a QC Data Integrity and Compliance (DICO) Champion and promote a strong culture of data integrity, electronic compliance, and inspection readiness.


• Ability to interpret analytical data, identify trends, prepare quality metrics, and communicate findings effectively.


• Knowledge and practical understanding of electronic laboratory systems and computerized systems, including audit trails, electronic records, electronic signatures, user access, and system-generated data.


• Strong audit and inspection readiness mindset, with the ability to organize and provide accurate laboratory documentation and supporting information in response to internal, customer, and regulatory audits/inspections.


• 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 or Associate's degree in science.


• 3+ plus years of experience in a QC l.

For more details, please visit https://www.piramalcriticalcare.com/global/