Quality Engineer

Lead quality management system improvements, audits, investigations, CAPA activities, and cGMP compliance programs within regulated pharmaceutical, biotechnology, or chemical manufacturing environments.

Job Responsibilities

• Lead programs and improvement activities to maintain quality management system effectiveness

• Ensure quality system activities comply with ISO and GMP requirements

• Lead customer complaint investigations

• Work directly with customers and raw material suppliers during complaint investigations

• Manage GMP, regulatory, customer, and internal audit activities

• Recommend and implement audit gap closure activities

• Perform internal audits at other sites as required

• Participate in supplier audits as required

• Maintain Corrective and Preventive Action program activities within assigned scope

• Identify and implement effective corrective actions

• Ensure facility cGMP compliance is maintained

• Identify and implement cGMP improvement programs

• Provide GMP and GDP training to site personnel

• Lead improvement efforts for quality metrics, including complaints, complaint response time, and CAPAs

• Provide input to Management of Change processes

• Perform statistical evaluations for process and quality trending

• Lead validation activities for new products and changes to existing processes or products

• Work with supplier quality personnel to resolve quality issues impacting site performance

• Work with supplier quality personnel to resolve customer complaint issues

• Partner with external customers, operations leadership, plant operations, R&D, procurement, commercial, and quality teams

• Investigate and resolve process and product quality issues

• Perform additional duties as assigned

Job Requirements

• Bachelor’s degree in Chemistry or other science field

• 3+ years of experience in a GMP manufacturing facility

• 3–5 years of quality assurance experience

• 5+ years of experience in quality engineering or a related role

• Experience in pharmaceutical, biotechnology, or chemical environments

• Experience in cGMP or ISO 9000 regulated environments

• Familiarity with chemical nomenclature

• Knowledge of Quality Control testing and methods

• Experience with CAPA programs

• Experience with GMP, regulatory, customer, or internal audits

• Experience with customer complaint investigations

• Experience with statistical evaluations, process trending, or validation activities

• Ability to work in a manufacturing facility and wear required PPE

• Ability to support occasional domestic travel

Preferred Skills

• ISO quality system experience

• GMP and GDP training experience

• Supplier audit experience

• Supplier quality experience

• Management of Change experience

• Complaint response time improvement experience

• CAPA metric improvement experience

• Process validation experience

• Product validation experience

• Cross-functional quality investigation experience

Pay: 36-43/hr

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details: $36.00 to $43.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

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.