Quality Records Specialist
American Cybersystems, Inc.

Job Info

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Innova Solutions is immediately hiring a Quality Records Specialist

Job Title: Quality Records Specialist
Position type: Full-time Contract
Duration: 12 Months
Location: Summit, NJ 100% Onsite

As a Quality Records Specialist, you will:
• The Global Supplier Quality, External QC -Vector will process external deviation and change records from our Contract Test Laboratories (CTL). Other duties may include. Coordinate shipping and testing of samples for lot release, PPQ, PSQ and will compile vendor documentation to generate a CoA/CoT.
• This role will partner cross functionally with Global Product Quality, External Manufacturing Supply Chain, and Global Supplier Quality to release vector in a timely manner for commercial, clinical and early development programs.

Required Competencies:
• Experience with deviation and change control management, preferably with Infinity systems
• Strong organizational skills, including ability to follow assignments through to completion
• Ability to work in a fast-paced environment, meet deadlines, and prioritize work from multiple projects
• Excellent verbal and written communication skills, and ability to work within inter-disciplinary and cross-functional teams
• Detail oriented with demonstrated application in problem solving
• With moderate oversight from manager, think strategically and understand global impact of decisions

Desired Competencies:
• Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition
• Experience within Cellular Therapeutics and/or gene-based products. Experience with biologics will be considered.
Experience with Clinical and/or Commercial products manufacture, supply and post-approval change management
• Knowledge of applicable FDA/EMA regulations in the biotechnology industry
Experience managing external suppliers and other supply chain issues
• Experience with Quality Systems (change control, deviation and investigation)

Education and Experience:
• Bachelor's degree required in relevant scientific discipline, prefer 3 years' experience in biotherapeutics or biomanufacturing QC/QA, or an equivalent combination of education and experience.

Duties And Responsibilities:
• Initiation, facilitation, and tracking of quality records
• Provide regular communication and metrics for status of quality records
• Effectively communicate issues, risks and proposed solutions within the organization
• Provide communication, support, and guidance to CTLs within the QA vector and upstream material team
• Other duties may include:
• Working closely with other GSQ QC members to submit and track sample material for testing at CTL
• Create and revise SOP
• Create and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT)
• Enter data and retrieve information from Sharepoint and Smartsheet testing trackers

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
Sara.Almas@innovasolutions.com

PAY RANGE AND BENEFITS:
Pay range: $28 - $ 29.96Per 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 hr@innovasolutions.com 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.

This job has expired.