Overview
Quality Assurance Engineer Jobs in Troy, AL at Business Integra Inc.
Business: Critical Care
Department: Quality Control
Location: Bethlehem
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
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 (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
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
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.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
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.
Title: Quality Assurance Engineer
Company: Business Integra Inc.
Location: Troy, AL
