- Working experience of deviation investigations utilizing root cause analysis tools.
- Working experience in the CAPA process and ability to identify and verify effectiveness.
- Technical writing skills and ability to collaborate effectively in cross functional teams.
- Proven ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements.
- Ability to support health authority inspections.
- Knowledge of data trending and tracking, including use of statistical analysis software a plus.
- Demonstrate advanced problem-solving ability / mentality, technical adeptness and logical thinking.
- Ability to set priorities, manage timelines and effectively react/manage changing priorities.
- Ability to work with management (global and site) and support corporate and departmental goals.
- Ability to communicate honestly, transparently and effectively with peers, department management and cross functional peers.
- Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system).
- Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality Control.
- Ability to train new team members on the investigation process
- Requires a Bachelor's Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred).
- Minimum 3 years of relevant work experience, preferably in a health authority regulated environment.
- Previous experience working in a biopharmaceutical manufacturing facility is preferred (CAR T a plus).
- An equivalent combination of education and experience may substitute.
- Conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools.
- Lead investigations and cross functional investigation teams, and close reports in a timely manner
- Perform GEMBA walks with stakeholders to better understand process steps and evaluate Root Cause Analysis.
- Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness.
- Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy.
- May Initiate change control documentation
- Identify functional area SMEs to perform impact assessments as part of the change management process.
- Ensure all investigations are completed in a timely manner. Notify stakeholders of any delays in a timely manner.
- Provide technical support for manufacturing investigations / CAPAs / change controls as needed.
- Support deviation investigation defense during audits and site inspections for QC compliance related inquiries.
- Handle complex issues and solve problems with minimal guidance.
- Provide training to new investigations team members
- Serve as author or technical reviewer of departmental procedures as appropriate.
- Support manufacturing and Quality Control testing of CAR T products as needed.
- Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems.
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Scientist/Engineer - Summit, United States - MassGenics
Description
Innova Solutions is immediately hiring a Scientist/EngineerJob Title:
Scientist/Engineer
Position type:
Full-time Contract
Duration: 12 Months
Location:
Summit, NJ (100% onsite)
As a Scientist/Engineer you will:
The Scientist/Engineer is responsible for leading manufacturing and QC investigation reports in support of S12 CAR T operations.
This includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive actions (CAPA), and troubleshooting complex problems.
The successful incumbent must interface closely with different functional organizations, including Quality Assurance teams.Required Competencies:
Education and Experience:
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.
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:
$45.00 -$ 48.94Per 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:
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 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.
