Quality Assurance Lab Owner

Quality Assurance Lab Owner

Location : Malvern, PA
Salary : $60,000–$70,000/year

Job Overview

We are seeking an experienced Quality Assurance Lab Owner to maintain and continuously improve laboratory operations and quality systems within a manufacturing facility. This position is responsible for ensuring compliance with regulatory requirements, customer standards, and company quality procedures while supporting continuous improvement initiatives.

The Quality Assurance Lab Owner will oversee lab processes, testing activities, documentation, training, and quality systems while working closely with the Quality Assurance Manager and cross-functional teams.

Responsibilities

• Maintain and continuously improve quality systems, laboratory processes, and documentation practices.

• Ensure compliance with applicable regulatory requirements, customer expectations, and company standards.

• Support FDA, customer, and internal audits.

• Assist with quality management system activities including document control, complaints, internal audits, nonconforming material reports, CAPA processes, inspections, and quality record maintenance.

• Create, maintain, and approve documentation including work instructions, SOPs, records, and lab-related procedures.

• Ensure GMP standards and quality processes are followed throughout the facility.

• Provide GMP training and support quality-related training initiatives.

• Perform internal audits and support audit preparation activities.

• Manage laboratory operations including testing, documentation, calibration support, and validation activities.

• Perform incoming, in-process, sensory, laboratory, and finished product testing as needed.

• Maintain strong working relationships with Production, Quality, Engineering, customers, and external partners.

• Support customer quality requirements, specifications, and documentation requests.

• Manage laboratory staffing needs, training, qualifications, and performance reviews.

• Provide backup support for laboratory technicians as needed.

• Maintain relationships with outside laboratories and support external testing requirements.

• Support water system testing, documentation, and validation activities.

• Participate in customer and company meetings as needed.

Qualifications

• Minimum 1 year of lab and/or sensory qualification experience required.

• Experience in quality assurance, laboratory operations, or a manufacturing quality environment preferred.

• Knowledge of FDA 21 CFR Part 820 preferred.

• Strong understanding of GMP requirements and quality systems.

• Experience supporting audits, documentation control, CAPA, and inspection processes.

• Strong computer skills, including Microsoft Word, Excel, and inventory systems.

• Ability to work cross-functionally and collaborate with multiple teams.

• Strong attention to detail with the ability to maintain accurate records and reports.

• Ability to make decisions, prioritize workload, and adapt to changing business needs.

• Strong communication skills with the ability to work effectively with employees, customers, and leadership.

• Must be able to read, write, and speak English.

Physical Requirements & Work Environment

• Ability to stand for extended periods of time.

• Ability to lift and move items weighing 25–30 pounds.

• Comfortable working in a manufacturing environment.

• Must be willing to become sensory certified, including product tasting and smelling.

• Ability to work overtime or off-shift hours as needed.

If you are an experienced quality professional looking for an opportunity to lead laboratory operations and support continuous improvement within a growing manufacturing environment, we encourage you to apply.

Pay Details: $60,000.00 to $70,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.