Quality Assurance Specialist

Our client is seeking a Quality Assurance Specialist to assist with day to day product release and review of documentation.

Responsibilities:

Maintain the company’s quality inspection and product release programs for incoming and in process materials, components, processes, finished goods, and product returns.

Plan, execute, and oversee product inspection and testing for quality and conformance to specifications and deliverables.

File and maintain all records associated with the Quality Department both written and electronically.

Review purchased products or components according to inspections plans; provide input to the acceptance of product and future purchases from suppliers.

Document data obtained during all quality assurance activities, consistent with company policies and procedures.

Communicate significant issues or developments identified during quality assurance activities and provide recommended process improvement to management.

Review sterility documentation, generate batch reports, and Certificates of Sterility.

Prepare Certificates of Conformance and Certificates of Analysis for customers upon request or as required by customer agreements.

Handle product returns process.

Assist in the preparation, revision, and distribution of ISO documentation; assist in scheduling internal audits and ensure they are being done as scheduled, assisting internal auditors as needed; assist in preparation of 3rd party audits.

Initiate and monitor Non-Conforming Material and Corrective/Preventive Action processes in NC.

Monitor existing processes and develop alternatives/improvements to drive efficiencies, ensure quality and on time delivery, and remove waste.

Taking samples of the environment while manufacturing is running (air, water, and surface sampling looking for contamination)

Skills:

Quality assurance, Batch record, Document control, Batch record review, aseptic technique, environmental monitoring, cleanroom, Inspection, Audit, Fda, Capa, Quality control, Pharmaceutical, Quality check

Additional Skills & Qualifications:

Bachelor’s Degree/Associates not required, if have degree would like it to be in biology, microbiology, or environmental science

Three to five years’ related experience and/or training if associates degree or just GED

Knowledge and experience with Six Sigma and Root Cause Analysis.

Good working knowledge of MS Office and ERP system software; LIMS/QMS experience desirable.

Ability to use precision measuring instruments including equipment and personal computer to input data.

Prior experience with environmental monitoring (air, water, surface, and personnel).

Open to industry experience but prefers textile or pharma

Previous experience with ISO 9001 system in manufacturing environment. Cleanroom experience (ISO Class 4-8) a plus.

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.