FirstBank Jobs

Description:

The Principal Quality Assurance Engineer is responsible for the oversight and primary SME for quality assurance and validation for new products / projects. This position requires strong technical and training skills of quality systems. Develop quality and validation project timelines and manage a sub team of 2 Quality Engineers to ensure key milestones are accomplished.

SME and Quality approver for GxP documentation associated with new products / projects through the project lifecycle.

Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

Review and approve Change Control/Management Documents involving product or process changes.

Key personnel for FDA or other regulatory agencies for on-site audits.

Drive for resolution of product complaints, exceptions, corrective actions, OOS’s, and/or safety issues.

Assemble, analyze and report QA data to ensure regulatory compliance, identify trends and to identify areas of improvement.

Conduct quality audits and develop and assess subsequent corrective action recommendation(s).

Developing procedures, statistical evaluations, and remediation of systems.

Additional areas of responsibility may include developing sampling plans and standard operating procedures; providing quality training; actively participating in Material Review Board meetings; and assisting in preparation of regulatory submissions.

This role is more focused on review of regulatory documentation and making decisions from there. Some technical writing but mostly reviewing others' work and giving suggestions on what to do next. Actively involved in understanding the process and making QA decisions regarding this new process/product.

Skills:

quality assurance, batch record review, technical writing, Quality Investigation, pharmaceutical, audit, GMP, cGMP, FDA

Additional Skills & Qualifications:

Bachelor of Science in Biology, Chemistry, Life Sciences or related field required.

8 or more years of relevant experience required.

3 or years of experience in supporting on-site inspections for regulatory agencies.

2 years of demonstrated leadership experience on a project or in a position with direct reports

Significant experience investigating exceptions and other variances.

Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes and facility systems.

Working knowledge of cGMP guidelines and their application in a controlled aseptic environment.

Experience Level:

Expert 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.