Quality Assurance Specialist

Description:

POSITION SUMMARY: As a Quality Assurance Specialist you will review and confirm procedures, track and follow up on commitments and participate in audits and investigations. Tracking Compliance metrics and overseeing vendor qualification and status.

KEY RESPONSIBILITIES:

Participates in audits, CAPA's, and investigations.

Performs internal audits and effectiveness checks.

Reviews SOP, job aids, and other documents for accuracy and completeness.

Evaluate & determine current regulations related to Clinical Research against site SOP's and processes.

Participates in Computer System Validation (CSV) efforts.

Skills:

Quality assurance, cGXP, Sop, Fda

Top Skills Details:

Quality assurance,cGXP,Sop,Fda

Additional Skills & Qualifications:

REQUIRED QUALIFICATIONS:

3-5+ years experience in Quality.

Good working knowledge of regulated environments.

Trained on cGXP.

Excellent communication skills & understanding of SOP/departmental processes.

Excellent reporting writing skills & ability to adhere to strict timelines.

PREFERRED QUALIFICATIONS:

Experience within a clinic, hospital, pharmaceutical, or similar type environment.

Experience responding to audits by sponsors and government agencies.

Computer System Validation experience.

Experience with MasterControl.

Experience with conducting and/or evaluating CAPA's and investigations.

Experience Level:

Intermediate Level

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.