Job Title: Quality Assurance Technician

Job Description

Perform reviews of all In-process and Final Product testing for accuracy and completeness in a timely manner to meet company objectives. Write, implement, and/or edit SOPs as needed or for continuous improvement efforts. Act as a subject matter expert for QC testing assays and assist with troubleshooting issues, assay verification, and perform training and testing assays if needed. Perform equipment validation as needed. Spearhead actions to compile data, document results, report on and close the company's process deviations, NCRs, CAPAs, and Complaints. Verify implementation of corrective actions to ensure continuous improvement. Maintain the quality system in a state of inspection readiness by ensuring ongoing compliance with FDA, current ISO, and IVDD/IVDR regulations. Review and approve quality control assay data and file as necessary, report non-conformances, file completed quality records, and maintain data trending databases and records. Maintain and systematically review relevant department SOPs and coordinate with QA/QC/RA Department on revisions when required. Actively participate in continuous improvement opportunities to identify efficiencies and compliance improvements to benefit department operations or the organization at large. Perform other duties as assigned. Contribute to the maintenance of the company's process deviation, NCR, CAPA, and Complaint systems, and verify implementation of corrective actions to ensure continuous improvement.

Responsibilities

• Perform reviews of all In-process and Final Product testing for accuracy and completeness.
• Write, implement, and/or edit SOPs as needed or for continuous improvement efforts.
• Act as a subject matter expert for QC testing assays, assist with troubleshooting issues, assay verification, and perform training and testing assays.
• Perform equipment validation as needed.
• Compile data, document results, report on and close process deviations, NCRs, CAPAs, and Complaints.
• Verify implementation of corrective actions to ensure continuous improvement.
• Maintain the quality system in a state of inspection readiness, ensuring ongoing compliance with FDA, current ISO, and IVDD/IVDR regulations.
• Review and approve quality control assay data, report non-conformances, file completed quality records, and maintain data trending databases and records.
• Maintain and systematically review relevant department SOPs and coordinate revisions with QA/QC/RA Department.
• Actively participate in continuous improvement opportunities.
• Perform other duties as assigned.

Essential Skills

• 3-5 years experience in Quality in GMP environment.
• Working knowledge of current ISO, FDA 21 CFR 820, and IVDD/IVDR regulations.
• Ability to respond to internal and external quality audits and perform root cause analysis and risk assessment activities.
• Knowledge of QC testing procedures, current ISO, and 21 CFR Part 820 regulations.
• Proficient with Microsoft Office software; experience building and using databases (e.g., Microsoft Access, Excel) preferred.
• Excellent technical writing, communication, and organizational skills.
• Attention to detail.
• Hands-on approach to troubleshooting and resolving quality-related issues.
• Detail and Quality focused with strong organization, persuasion, and negotiation skills.
• Ability to present information and respond to questions from various levels within the organization.
• Thrives in a fast-paced, collaborative environment, works efficiently under pressure, within deadlines or other time essential constraints.
• Strong work ethic and ability to excel within a rapidly changing and growing organization.

Additional Skills & Qualifications

• Degree in life sciences-related field required, such as Biology, Chemistry, Biochemistry, or equivalent degree in the sciences.

Work Environment

8-12 month contract that may be extended. Work hours are from 8:00am to 4:30pm Monday to Friday. The company offers a small company feel but is backed by a large corporation, providing strong job security. Enjoy breakfast provided every Friday, summer cookouts, and ice cream socials. There is potential for a raise after the contract period, though it is not guaranteed

Pay and Benefits

The pay range for this position is $25.00 - $28.00/hr.

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)

Workplace Type

This is a fully onsite position in Franklin,MA.

Application Deadline

This position is anticipated to close on Mar 31, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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.

Salary : $25 - $28