QA Specialist

Actalent; Davis (CA); On-site; USD 34,000 - 44,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Paid time off

Job summary

Actalent is seeking a Quality Assurance Specialist in Davis, CA to implement and oversee the Quality Documentation System Program, aiming to boost operational efficiency and ensure regulatory compliance. The role focuses on audits, training, CAPA, and robust documentation control.

You will review batch records, manage NCRs, and support both internal and external inspections, while driving continuous improvement across processes and operations.

Qualifications

• Experience in quality assurance and quality control within a regulated environment.
• Experience reviewing batch records for GMP/FDA compliance.
• Knowledge of FDA regulations, GMP, and related frameworks.
• Proficient in QA/QC document control and SOP management.
• Experience supporting internal and external audits.

Responsibilities

• Oversee Quality Documentation System Program to improve efficiency and ensure compliance.
• Conduct internal quality audits and follow up on findings.
• Deliver training on quality processes and regulatory expectations.
• Identify process improvements to enhance quality and efficiency.
• Manage NCRs and corrective actions.
• Review batch records for accuracy and regulatory compliance.
• Support inspections by internal teams and regulatory authorities.

Skills

Quality assurance

Regulatory compliance

Audits & inspections

Documentation control

Root cause analysis

Communication

Data trending

Record review

Training delivery

Education

Biology or related field

Job description

Job Description

The Quality Assurance Specialist is responsible for implementing and overseeing the Quality Documentation System Program to enhance operational efficiency and ensure compliance with regulatory and internal quality standards. This role plays a key part in maintaining robust quality systems, supporting audits and inspections, and driving continuous improvement across processes and operations.

Job Title: QA Specialist

Job Description

The Quality Assurance Specialist is responsible for implementing and overseeing the Quality Documentation System Program to enhance operational efficiency and ensure compliance with regulatory and internal quality standards. This role plays a key part in maintaining robust quality systems, supporting audits and inspections, and driving continuous improvement across processes and operations.

Responsibilities

• Implement and oversee the companys Quality Documentation System Program to ensure it is effective, compliant, and aligned with operational needs.
• Conduct internal quality audits to assess compliance with procedures, GMP, and regulatory requirements, and follow up on findings.
• Deliver personnel training on quality processes, documentation practices, and regulatory expectations, and provide direct feedback on quality status to staff and management at all levels.
• Identify process and operational improvements that enhance quality, efficiency, and consistency across departments.
• Identify critical control points within processes and implement appropriate quality procedures to manage and mitigate risks.
• Create, implement, and maintain departmental standard operating procedures (SOPs) and forms to support consistent and compliant operations.
• Review batch records and other quality-related records and documents to ensure accuracy and compliance with internal procedures, GMP, FDA, and other regulatory requirements.
• Perform trending analysis on quality data to identify patterns, recurring issues, and opportunities for corrective and preventive actions.
• Provide support during inspections and audits conducted by internal teams and external regulatory authorities.
• Manage nonconformance reports (NCR) and corrective action processes, ensuring issues are documented, investigated, and resolved effectively.
• Oversee QA/QC document control activities, including the management, revision, and archival of controlled documents.
• Serve as a liaison with national and international regulatory authorities, facilitating communication and documentation as needed.
• Perform additional quality-related duties as assigned by supervisory or management personnel.

Essential Skills

• Demonstrated experience in quality assurance and quality control within a regulated environment.
• Hands-on experience with batch record review, including verifying completeness, accuracy, and compliance with GMP and FDA requirements.
• Strong knowledge of FDA regulations, GMP, and other relevant regulatory frameworks.
• Proficiency in QA/QC document control, including creation, revision, and management of SOPs and controlled documents.
• Ability to implement and manage a Quality Documentation System Program effectively.
• Experience conducting internal audits and supporting external inspections and audits.
• Skill in identifying critical control points and establishing appropriate quality procedures.
• Ability to perform trending analysis on quality data and translate findings into actionable improvements.
• Strong communication skills, with the ability to provide clear feedback on quality status to staff and management.
• Excellent organizational skills and attention to detail when reviewing records and documentation.

Additional Skills & Qualifications

• Education in biology or a related scientific field.
• Experience working with national and international regulatory authorities.
• Proven ability to identify process and operational improvements and drive continuous improvement initiatives.
• Comfort working in a collaborative team environment with dynamic, communicative colleagues.
• Ability to adapt to both in-office and remote work settings, depending on business needs and personal preference.

Work Environment

The organization operates with a close-knit team of approximately 5060 people, creating a collaborative environment where colleagues support each others growth. The culture is energetic and team-oriented, with individuals who have strong, dynamic personalities and value open, effective communication. The role offers flexibility in work location and can be performed in-office, hybrid, or fully remote, depending on how the individual prefers to work. Some team members already work remotely, and the company is open to someone who is entirely remote. The setting combines the agility and feel of a smaller company with access to global resources and growth opportunities, particularly in the diagnostics space, which is experiencing significant expansion due to increased testing needs.

Job Type & Location

This is a Contract to Hire position based out of Davis, CA.

Pay And Benefits

The pay range for this position is $25.00 - $32.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave).

Job Type & Location

This is a Contract to Hire position based out of Davis, CA.

Application Deadline

This position is anticipated to close on Oct 30, 2026.

Workplace Type

This is a fully onsite position in Davis, CA.

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 [e-mail] 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.