Senior Quality Control Analyst

Piramal Critical Care, Inc.; Bethlehem (Northampton County); Vor Ort; USD 70.000 - 95.000; Vollzeit

Zusammenfassung

Piramal Critical Care, Inc. is seeking a Senior Quality Control Analyst to support testing of in-process material, bulk drug substance, finished drug product, and stability samples.

You will ensure data integrity, audit readiness, and compliant documentation across cGMP environments. The role involves instrument calibration, electronic systems oversight, and collaboration with internal and regulatory audits.

Qualifikationen

• Bachelor’s degree or Associate’s degree in science.
• 3+ years of experience in a QC lab environment.
• Knowledge of cGMP, quality and safety norms in a regulated industry.
• Experience with data integrity and electronic compliance is preferred.
• Experience supporting internal, customer or regulatory audits/inspections preferred.

Aufgaben

• Perform testing on in-process material, bulk drug substance, finished drug product, and stabilities.
• Maintain QC compliance with electronic systems and computerized laboratory applications.
• Assist in preparing responses to audit observations and information requests.
• Serve as a QC Data Integrity and Compliance (DICO) Champion.
• Perform calibration and troubleshooting on instruments (GC, HPLC, UV/Vis, IR, etc.).
• Prepare quality metrics for turnaround times and data trends.
• Oversee training of new hires and conduct peer data reviews.

Kenntnisse

Critical Thinking

Customer service

Data Integrity Champion

Analytical Data

Electronic Lab Systems

Audit Readiness

Communication skills

Confidentiality

Training skills

Ausbildung

Science degree

Tools

SAP

MS Office

Ensur

Openlab

LabX

TrackWise

CaliberLIMS

Jobbeschreibung

About the company

Be the First to Apply 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. For more details, please visit https://www.piramalcriticalcare.com/global/

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.

Essential Duties and Responsibilities

• 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 applies 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

• 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 lab environment
• Understand chemical processes and reactions
• Prior experience with data integrity, electronic compliance, computerized laboratory systems, or serving as a quality/data integrity champion is preferred
• Experience supporting internal, customer, or regulatory audits/inspections preferred.
• Awareness of cGMP, quality and safety norms and requirements in a regulated industry
• Usage of technology tools such as SAP, MS office, Ensur, Openlab, LabX, TrackWise, CaliberLIMS is preferred.
• Experience with quality metrics, laboratory performance monitoring, and trend analysis preferred.

Physical Demands

Physical Effort (Occurrence frequency for each activity) Activity N/A Occasionally Frequently Continuously Sitting/Standing/Walking: Frequently Balancing/Kneeling: Occasionally Crouching/Stooping: Occasionally Crawling/Climbing: Occasionally Reaching/Working Overhead: Frequently Keyboard Use/Repetitive Hand Motion: Continuously Pushing/Pulling (up to 50 pounds): Occasionally Lifting/Carrying (up to 50 pounds): Occasionally General Oversight and Direction: Receives moderate to limited supervision working from objectives set by Manager.

Equal Employment Opportunity

Piramal Critical Care is committed to Equal Employment Opportunity. It is the policy of the Company to encourage and support equal employment opportunity for all associates and applicants without regard to age, sex, race, color, ancestry, religious creed, national origin, pregnancy, physical or mental disability, medical condition, marital status, political affiliation, sexual orientation, disabled veteran or Vietnam Era Veteran Status. Americans with Disabilities Act Applicants as well as employees who are, or become, disabled must be able to perform the essential job functions either unaided or with reasonable accommodation. The organization shall determine reasonable accommodation on a case-by-case basis in accordance with applicable law.

Employee Job Responsibilities

You are expected to follow all policies, procedures and guidelines, conducting yourself in ways that protect the interests and safety of all employees and the company. The above statements reflect the general duties and responsibilities considered necessary to perform the essential functions of the job. This document should not be considered a fully detailed description of all the work requirements of the position. Piramal Critical Care may change the specific job duties with or without prior notice based on the needs of the organization.

Company Background

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group. PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.