Quality Assurance Floor Lead
System One
Job Title: Quality Assurance Lead
Location: Warminster, PA
Type: Contract
Schedule: Monday - Friday 1st shift 7AM-3PM
2nd shift 3PM - 11PM
Overview:
We are seeking two experienced Quality Assurance Floor Leads to provide QA oversight personnel on the production floor, ensuring full compliance with cGMP regulations, company SOPs, brand owner expectations and batch record requirements.
This role is ideal for a hands-on QA professional with strong attention to detail, a background in pharmaceutical manufacturing, and the ability to lead by example through on-floor oversight and communication.
Key Responsibilities:
+ Production Oversight:
Provide quality oversight during all production activities, including liquid filling operations for OTC and topical products.
+ Line and Room Clearance:
Supervise line and room clearances to ensure compliance prior to production start.
+ Random Inspections:
Perform and document random quality inspections throughout production to verify GMP adherence and data integrity.
+ Sampling & Testing:
Oversee raw material and bulk sampling, environmental monitoring (air sampling), and in-process checks to ensure product quality.
+ Conflict of Interest Monitoring:
Verify and document that no personnel involved in production have relatives employed to maintain integrity and impartiality.
+ Team Communication:
Act as a liaison between the CMO and Brand Owner, helping to enforce quality standards. Report back daily to Brand Owner Quality Assurance group.
+ Documentation & Compliance:
Maintain complete and accurate records in accordance with FDA guidelines, internal SOPs, and cGMP standards.
Qualifications:
+ Minimum 5 year of QA experience in a pharmaceutical or medical device production environment
+ Pharmaceutical background is required — QA experience in food, cosmetics, or supplements will not be considered
+ High School Diploma or equivalent
+ Proficient in: Line release and clearance, Bulk and raw material sampling, Final inspection and documentation review, Liquid filling operations for OTC and topical products
+ Familiar with environmental monitoring and GMP documentation standards
+ Strong written and verbal communication skills
+ Basic Microsoft Office proficiency
+ Ability to distinguish colors and lift up to 50 lbs
+ Willingness to work assigned shift, including overtime and weekends as needed
System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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