Overview
Manufacturing Quality Assurance Specialist Jobs in Lexington, Kentucky, USA at Piramal Pharma Limited
Manufacturing
Quality Assurance
Specialist
Join to apply for the Manufacturing Quality Assurance Specialist role at Piramal Pharma Ltd.
Job Description
Manufacturing QA Specialist – Night shift
Business: Pharma Solutions
Department:Quality Assurance
Location: Lexington
Job Overview
The Manufacturing QA Specialist helps to ensure compliance with regulations and standard operating procedures by performing quality oversight activities during the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products.
Reporting Structure
Reports to QA Supervisor.
Key Responsibilities
Review executed batch records and executed protocols and work with departments to address and correct issues.
Review pest control, calibration, HEPA certification, logbooks, and work order documentation.
Execute “on the floor” activities (line clearances, product inspection, interim problem solving, etc.).
Provide QA oversight and perform walkthroughs of manufacturing areas.
Troubleshoot systemic GMP issues.
Provide leadership on projects and within systems that interface with other departments.
Provide SME support, review and approval during meetings, audits, investigations, technical reports, etc.
Execute assigned training and development plan.
Education Requirements
High school education or equivalent.
Bachelor’s Degree in the physical or biological sciences or related scientific field preferred.
Experience
Previous experience performing quality related activities within a manufacturing environment, pharmaceutical manufacturing preferred.
Previous experience working within strict regulatory guidelines, cGMP or FDA preferred.
Competencies
Working knowledge of cGMP and applicable FDA regulations.
Proficiency in Microsoft Office applications (Word, Excel, Outlook, and Access).
Demonstrated ability to effectively communicate both verbally and in writing.
Ability to read and follow written instructions.
Detail oriented.
Understanding of sterile manufacturing preferred.
Technical writing skills preferred.
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.
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.
About The Team
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle.
Seniority Level:
Entry level
Employment Type:
Full-time
Job Function:
Quality Assurance
Industries:
Pharmaceutical Manufacturing
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Title: Manufacturing Quality Assurance Specialist
Company: Piramal Pharma Limited
Location: Lexington, Kentucky, USA
Category: Quality Assurance – QA/QC (Quality Control / Manager, Quality Technician/ Inspector, QA Specialist / Manager, Quality Engineering), Manufacturing / Production (QA Specialist / Manager, Quality Engineering)
