Quality Control Analyst

Job Description

Business: Critical Care

Department: Quality Control

Location: Bethlehem Plant

Schedule: 7:00pm-7:30am

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

Directly 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

• 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

General Oversight And Direction
Receives moderate to limited supervision working from objectives set by Manager. Employee organizes and carries out most assignments in accordance with standard practices, instructions or previous training. Employee handles some situations independently.

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.

About Us
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.

Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.

About The Team
Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders.

PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators.

Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space.

Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment.