QA Manager

Job Title: Quality Assurance ManagerJob Description

The Quality Assurance Manager oversees the laboratory's Quality Management System to ensure consistent quality, robust policies, and regulatory compliance. This role leads continuous improvement initiatives, verifies adherence to standards, and supports the laboratory in achieving its mission and objectives. The Quality Assurance Manager serves as a key liaison between laboratory operations, regulatory requirements, and clients, while managing QA staff and fostering a strong quality culture.

Responsibilities

• Lead the laboratory's quality function proactively and foster a culture of continual improvement in quality, processes, and procedures.
• Coordinate, implement, and maintain the laboratory's Quality Management System in collaboration with the Laboratory Director, Laboratory Manager, Group Leaders, and laboratory staff.
• Oversee document control and quality records, ensuring that controlled documents and records are accurate, current, and compliant with applicable standards.
• Manage training documentation to ensure personnel are properly trained, qualified, and documented for their assigned responsibilities.
• Plan, coordinate, and support internal and external audits, including scheduling, execution, documentation, and follow-up on findings.
• Administer corrective and preventive actions (CAPA) and continuous improvement activities, ensuring timely resolution and effective preventive measures.
• Coordinate proficiency testing, including scheduling, reporting results, and following up on any issues or non-conformances identified.
• Manage supplier qualification and traceability processes, ensuring that suppliers meet quality and regulatory expectations.
• Serve as archivist for Good Laboratory Practice (GLP) study-specific records, ensuring proper storage, organization, and traceability of critical documentation.
• Ensure internal audits of the Quality Management System are performed at least annually to maintain compliance with applicable standards and accreditation programs.
• Identify areas of non-conformance and opportunities for improvement, and drive actions to address findings from audits and reviews.
• Prepare special reports for regulatory agencies and clients, including summary reports of analytical results, external audit responses, FDA data packages, and ODA data packages.
• Verify that new method validations and method improvements comply with internal policies and applicable regulatory requirements.
• Write, review, and maintain Quality Management System standard operating procedures (SOPs) and related documentation in collaboration with the Quality Assurance Unit, Laboratory Manager, Laboratory Director, and other relevant departments.
• Review controlled laboratory documentation for compliance, accuracy, and quality, ensuring alignment with SOPs, laboratory practices, and regulatory requirements.
• Perform procedural audits of laboratory methods against applicable SOPs, laboratory procedures, and regulatory requirements to confirm accuracy and adherence.
• Provide periodic reports to the Laboratory Manager and Laboratory Director on laboratory quality performance, audit observations, findings, non-compliances, and non-conformances.
• Make recommendations for corrective actions and process improvements to enhance laboratory quality and compliance.
• Coordinate Annual Quality Review Meetings with laboratory management and compile data and information throughout the year to prepare the annual Management Review of the Quality System report.
• Coordinate and manage verification and maintenance of scheduled calibration for laboratory support equipment to ensure accurate and reliable operation.
• Assist sales and marketing teams by responding to quality assurance-related inquiries from existing and potential clients.
• Coordinate and conduct laboratory meetings to communicate updates on laboratory operations, regulatory changes, quality improvements, and quality issues.
• Coordinate and deliver quality assurance training for laboratory personnel to maintain and enhance quality awareness and competence.
• Supervise QA Associate and/or Assistant positions, including interviewing, making hiring recommendations, training new employees, planning and assigning work, directing daily activities, and appraising performance in accordance with organizational policies and applicable laws.

Essential Skills

• Strong leadership skills with the ability to influence, guide, and develop teams in a laboratory environment.
• Bachelor's degree in Chemistry or a relevant scientific discipline.
• Minimum 2 years (5-10 years ideal) of quality assurance experience in regulatory compliance, preferably at a corporate or national level.
• Experience in a high-volume, wide-scope laboratory environment.
• Experience with ISO or comparable quality management systems and standards.
• Experience with GLP (Good Laboratory Practice) or equivalent regulatory frameworks.
• Strong reading and writing skills, including the ability to draft and revise SOPs, reports, and manuals.
• Strong presentation skills, with the ability to communicate technical and quality-related information clearly to diverse audiences.
• Advanced math skills, including exponents, logarithms, statistics, and related quantitative concepts.
• Demonstrated ability to perform QA/QC procedures and audits in a laboratory setting.
• Proven problem-solving and analytical skills to identify root causes and implement effective corrective and preventive actions.
• Experience collaborating across departments and leading cross-functional teams.
• Experience managing change and driving continuous improvement within a quality or laboratory environment.
• Previous laboratory experience, preferably in an analytical laboratory setting.

Additional Skills & Qualifications

• Experience with ISO, NELAP, GLP, or equivalent accreditation or regulatory programs at a corporate or national level.
• Experience preparing and responding to external audits and regulatory inspections.
• Experience preparing regulatory and client-facing reports such as analytical summaries, audit responses, and data packages.
• Experience managing document control systems and quality records in a regulated environment.
• Experience coordinating proficiency testing and supplier qualification programs.
• Comfort working with complex quality documentation and multiple concurrent projects.
• Strong interpersonal and communication skills to effectively interact with laboratory staff, management, clients, and external stakeholders.

Work Environment

This role operates in a fast-paced analytical laboratory environment with a team of approximately six chemists, reporting into laboratory leadership. The typical schedule runs from 9:00 a.m. to 5:30 p.m. The position involves regular use of analytical laboratory equipment and instruments, with possible exposure to hazardous chemicals and solvents. Work requires frequent repetitive hand and wrist movements and the ability to hear and understand verbal instructions clearly. Reasonable accommodations are available for qualified individuals with disabilities. The workplace offers designated free parking in a downtown location and a collaborative, quality-focused culture. The organization provides a comprehensive benefits package that includes medical and vision insurance with a high level of employer premium coverage, dental insurance, health savings account options with employer contributions, flexible spending accounts, supplemental insurance options, legal and identity protection services, a 401(k) plan, paid time off, and 13 paid holidays. Employees also have access to partnerships with well-known retail brands' employee stores. The company regularly hosts monthly food events such as dinners, happy hours, and catered meals, along with a summer barbecue and family-friendly events like a "Kids to Work" day. A bonus program has historically provided an annual bonus approximately equivalent to one month's salary, subject to business performance and prorated for employees who join partway through the year.

Job Type & Location

This is a Permanent position based out of Portland, OR.

Pay and Benefits

The pay range for this position is $72000.00 - $72000.00/yr.

Benefits: Medical/vision insurance (company covers 100% of EE premium and 90% of dependent and HSA- company covers 100% of premium and contributes to HSA every month), dental insurance, LTD, FSA, supplemental insurance, LegalShield/IDShield, 401(k), PTO, 13 paid holidays, and partnership with Adidas and Columbia employee store.

Workplace Type

This is a fully onsite position in Portland,OR.

Application Deadline

This position is anticipated to close on Aug 1, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: 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.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.