QA Shop Floor Specialist from Innova Solutions

Innova Solutions is immediately hiring a QA Shop Floor Specialist.

Job Title: QA Shop Floor Specialist
Position type: Full-time Contract

Duration: 06 Months

Location: Bothell, WA

Pay range: $40 -$ 43.33 Per Hour

Work Schedule: 9:00pm - 7:30am, Sun - Wed

As a QA Shop Floor Specialist, you will:

The primary focus of the QA Specialist role will be to support routine clinical and commercial production to ensure consistent compliance with regulatory and industry expectations. Assist the QA department in maintaining the Quality focused culture at project by ensuring documentation is complete, accurate and that batch records are executed in accordance with approved and effective standard operating procedures and specifications. The QA Specialist primary role is on-the-floor and contributes with off-the-floor projects and activities that are just as significant as on-the-floor work.

Roles And Responsibilities:

• Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.  
• Provide Quality on-the-floor oversight including quality walk-throughs of the production, testing and warehouse locations to ensure practices fully adhere to cGMP.
• Provides technical knowledge and guidance towards GMP compliance during triage/troubleshooting activities. 
• Review deviations, product non-conformities, and GMP investigations to ensure compliant resolution and adherence to current Good Manufacturing Practices (cGMPs). 
• Own, review, and approve deviations, including Deviation classification and completion of Impact Assessments, as applicable.
• Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.  
• Oversee manufacturing operations from patient material receipt to drug product pack out.  
• May support internal and external audits, including documenting observations.
• Own and participate in review and approval for CAPAs.
• Identify and facilitate continuous improvement projects.
• Revise Standard operating Procedures as needed, and review/approve document revisions.
• Drives right first time (RFT) by providing direct training, guidance, and problem solving to peers.
• Provide training, coaching, and feedback for GMP guidance.
• Continue support of continuous improvement culture and operational excellence methodologies.
• Support change control initiatives as applicable.

Education and Experience:

Bachelor's degree in relevant science or engineering discipline is preferred. A minimum of associate degree and/or equivalent combination of education and experience is required.  

• 3-5 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing are preferred.  
• Hands-on experience with batch record review and product disposition is preferred.  
• Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, Deviations, Management Monitoring and Self Inspection auditing, QA reporting, and approval of GMP documentation.
• Strong computer skills with Word and Excel and other electronic manufacturing systems.  

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.

Thank you!

Sara Almas
Team Recruitment

PAY RANGE AND BENEFITS:

Pay range: $40 -$ 43.33 Per Hour

*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:

One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)

ClearlyRated® Client Diamond Award Winner (2020)

One of the Largest Certified MBE Companies in the NMSDC Network (2022)

Advanced Tier Services partner with AWS and Gold with MS

Website: https://www.innovasolutions.com/

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.

The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

American Cybersystems, Inc is acting as an Employment Business in relation to this vacancy.