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Form of workJob Description
We are seeking a Quality Assurance Specialist to join our team! In this role, you will play a pivotal role in ensuring that our products meet the highest quality standards while actively contributing to process improvement initiatives.
About Us: We are a flourishing & innovative biotech company, constantly pushing the boundaries of what's possible and committed to improving lives through cutting-edge research, development, and manufacturing of life-changing products.
Responsibilities:
You will work alongside a team of passionate professionals dedicated to maintaining the integrity of our products and processes and your experience in CAPA, and familiarity with ISO 13485 or ISO 9001, will be an invaluable addition to the team!
- Performs diluent checks, incubator temp checks & time checks, etc.
- Performs batch record/lot file reviews following good documentation practices and internal procedures in an efficient and timely manner.
- Assures that any observations/deviations are properly investigated and explained.
- Reviews and approves Nonconforming Material Reports.
- Provides support for the CAPA process to include CAPA investigation and closure.
- Maintains awareness of activities by routine direct observation of manufacturing processes. Interacts frequently with manufacturing staff to provide quality perspective on routine operations and support system. Addresses conditions/practices with appropriate personnel, documents and reports finding to Management.
- Assists departmental supervisor with writing and revising Standard Operating Procedures as necessary.
- Maintain Quality System reporting tools, such as error tracking spreadsheets and other documents as requested by management.
- Participates in quality and process improvement initiatives and project teams.
Requirements:
- Bachelor’s degree in biology, chemistry or related discipline (related work experience may substitute for a portion but not the entire education requirement)
- Related work experience in an FDA-regulated manufacturing environment is preferred.
- High attention to detail, with strong organizational, time management and multitasking skills.
- Demonstrates professionalism and sound judgment and strong oral and written communication skills.
- Demonstrated analytical and problem-solving skills.
- High degree of flexibility and the ability to lead others in adapting to change.
We Offer:
- Competitive compensation structure!
- Comprehensive benefits package
- Medical Insurance
- Dental Insurance
- Vision Insurance
- 401K
- Strong emphasis on employee development!
- We promote from within!
- A company culture that values your growth and success!
Do you have a passion for process improvement, Corrective and Preventive Actions (CAPA), and perhaps even exposure to ISO 13485 or ISO 9001 standards? If so, we have an exciting opportunity for you to join a dynamic and rapidly growing biotech company right here in Omaha, Nebraska!
Ready to take your career to the next level?
Apply Today!
Offering a boutique-style service, we have grown organically over the years through word-of-mouth referrals and have become the Agency of Choice for companies who need the right talent to join their firm.
Our Services Include Direct hire, Contract, or Contract-to-hire.
We have served a wide variety of firms in the Midwest and nationwide since 1998 and as a result we have come to truly know our client's culture, their business demands and subsequently their hiring needs. Everything is evolving in today's marketplace and the most innovative professionals are driving this market. The success of your company relies on how you can attract, engage and hire these people: this is where we can help.
A Dynamic Approach
"Over 85% of our business comes from referrals; that's a powerful testament to the quality of service we deliver. Companies want to be truly heard and understood when they are working with an agency to help them find and secure the best talent available. Many come to us because they're tired of the larger nationwide chains only providing mediocre candidates, and they want better results.
And that is what every company receives with us: better results."
- Kinga Wilson, Search Consultant and Owner of Insight Recruitment
