Role reports to VP, Quality Assurance and Operations

Duties and Responsibilities:

Ensures compliance in all company areas, with an emphasis on managing incoming inspection of raw materials, in-process testing, and finished products

Oversees and assists, internal and external audits, CAPAs, failure investigations, deviations, change control, non-conformance issues, equipment calibration and maintenance, maintenance of documentation & product quality records, validation programs

Works with manufacturing/production group members to implement corrective and preventative actions

Ensures site is compliant with applicable quality systems in support of customer audits

Reviews documents ensuring manufacturing and testing were conducted within the approved established framework (SOP’s, customer requirements, etc. )

Manages the flow and control of all documents pertaining to forms, document control, assigning numbers to SOP’s, revisions to SOP’s, and routing SOP’s to appropriate departments in compliance with ISO standards

Maintains a state of inspection readiness of key documents

Collaborates with Management to establish and meet targets and timelines

Supports organization where needed in other critical roles and functions as deemed critical by manager

Qualifications and Desired Skills:

Bachelor’s degree in a technical or scientific discipline and a minimum 2 years of Quality Assurance experience in a manufacturing facility

Additional experience may be considered in lieu of education

Contract manufacturing experience

Experience with ISO and cGMP systems and procedures

Excellent oral & written communications

Ability to operate independently, cooperatively, and apply critical thinking to complex problems to drive positive outcomes

Working knowledge of Excel, Word, Access, and ERP databases

Proof of COVID vaccination required for employment

“What’s in it for me?”

Our company is like a family. It sounds cliché, but it’s true. Perhaps you’ve spent too much time over the years dealing with office politics. ‘Colleagues’ who will step on you to get what they want. We’re not like that. We pull together as a team. You can always voice your opinions, honestly and openly. And we’ll help you just as much as you help us. Besides – life’s too short not to have fun at work. Having fun outside of work is important too, which is why every member of our team has three weeks’ vacation, right from the start.

But make no mistake – we’re very serious about achieving our goals. We’re also serious about taking care of our customers.

We offer a professional, collaborative, creative, and supportive environment with a competitive compensation package including health, dental, vision, life, profit sharing, short-term disability, 401(k) Plan, and more. 

Interested candidates should send a cover letter and resume to hr@qualitybiological.com.

Quality Biological provides specialized and classic media and buffers, custom formulations, and reagents, as well as other products, services, and research support to help accelerate timelines from concept to commercialization. qualitybiological.com