Overview
Pilot Plant QA Specialist/QMS Lead Jobs in Fall River, Massachusetts, USA at Cipla USA
Position: Pilot Plant QA Specialist (QMS) Lead
Job Title
Quality Assurance (QMS) Production Lead
FLSA Classification
Professional, Exempt
Work Location
Fall River, MA
Work Hours
General: 8:30AM to 5:00PM (may vary based on business needs)
Reports To
QA Manager
Purpose
The purpose of the Quality Assurance Production Lead (QMS) is to monitor and ensure product quality is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating procedures (SOPs) and to provide guidance to Quality Assurance associates.
Scope
The Quality Assurance Production Lead (QMS) is an individual contributor role and a member of the Inva Gen Pharmaceuticals Quality team. The position reports to the Quality Assurance Manager.
Key Responsibilities
Review of batch manufacturing/packaging records.
Release of raw materials, packaging materials, and finished products through approval of respective COA.
Review of engineering records such as temperature and humidity data calibrations, preventive maintenance records, pest control records, and contractor-related functions.
Review and approval of manufacturing/engineering non-conformance.
Review and approval of manufacturing/engineering change controls, deviation investigations, and CAPAs.
Review and approval of manufacturing/engineering qualification documents.
Provide daily/weekly updates to shop floor and management regarding quality highlights/concerns.
Create lessons learned for training as a communication mechanism to shop floor personnel.
Lead manufacturing quality associates on daily activities, including the assignment of weekly work schedules.
Perform training and onboarding of QA associates to ensure qualification prior to their duties.
Act as quality lead for all shop floor questions/concerns.
Act as back-up for shop floor QA associates.
Other duties as assigned by department head.
Education
and Experience
Bachelor’s degree, advanced vocational training, or education in pharmaceutical manufacturing, industrial management, or related field from an accredited college/university.
Master’s Degree or advanced training preferred.
Minimum of five (5) years of experience in quality assurance in a cGMP pharmaceutical manufacturing environment.
Technical Knowledge and Skills
Understanding of machines used in pharmaceutical manufacturing.
Ability to influence decision-making and facilitate work towards business goals.
Effective interpersonal skills and teamwork ability.
Capability to conduct troubleshooting, investigations, and root cause analysis.
Experience with compliance and regulatory audits.
Proficiency in Microsoft Office; experience with SAP is a plus.
Experience in Inhalation products (MDI) is a plus.
Professional and Behavioral Competencies
Proficient in English.
Self-starter with initiative.
Willingness to work any shift, including weekends if needed.
Knowledge of GMP and documentation practices preferred.
Effective communication skills.
Ability to work in a fast-paced environment, handling multiple tasks.
Excellent organizational skills.
Work Schedule and Other Information
Willing to work in a pharmaceutical manufacturing setting.
Availability for various shifts and weekends as required.
Relocation negotiable.
No remote work; PPE required in the work environment.
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Title: Pilot Plant QA Specialist/QMS Lead
Company: Cipla USA
Location: Fall River, Massachusetts, USA
Category: Quality Assurance – QA/QC (Quality Control / Manager, QA Specialist / Manager, Quality Technician/ Inspector), Manufacturing / Production (QA Specialist / Manager)
