Seeking a QA Specialist to support operations in Cleveland, OH.
The Quality Assurance Specialist is responsible for supporting the quality system processes and for maintaining quality assurance standards, processes, and controls. Mainly over HCLA product. (Hydrochloric acid).
The Quality Assurance Specialist collaborates closely with Manufacturing, Quality Control, Maintenance, Shipping, and Receiving. The incumbent must be able to perform in a fast-paced environment and be a self-starter. The QA Specialist is expected to work during normal business hours, Monday - Friday, but may be required to overtime or on weekends and/or holidays to support Manufacturing and Lot Release activities.

Job Description

• The generation, review, facilitation of corrections, and archival of documents used to support Good Manufacturing Practice manufacture of Final Product.
• Perform internal and external audits as assigned.
• Review and release raw materials, intermediate products and finished products.
• Perform review and approval of OOS, deviations, nonconformance, and investigation as required.
• Coordinate CAPA, OOS, deviations, nonconformance, and investigations
• Ensure systems are in compliance with current SOPs.
• Assist investigations and resolve potential product quality issues to improve efficiency.
• Assist with writing, revising, and approving standard operating procedures and work instructions.
• Review and approve SOP, protocols and reports as necessary.
• Coordinate and/or conduct GMP training and SOP training.
• Generate, publish, and manage quality systems metrics to drive continuous improvement.
• Scanning/archiving of GMP documents

Work Environment

• This job operates in a manufacturing setting and professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Some of the work will require exposure to loud noises or fumes in the plant facility, collaborating with officials, plant managers and employees.

Skills & Qualifications

• Bachelor's' degree in a scientific discipline or equivalent experience.
• At least 2 years' experience in cGMP/FDA environment (preferred) and ISO 9001 within relevant Quality Assurance/Compliance functions.
• Training experience a plus.
• Proficient with Microsoft Office tools, especially Excel.
• Experience with QT9 a plus

To apply, please email the recruiter at cpepe @ actalentservices.com to schedule a phone screening.
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.