Associate Director, Quality Assurance Operations

Duration: 3 Months

Location:Bedford MA

AsAssociate Director Quality Assurance Operationsyou will:

JobDescription:
Responsibilities

• Provide on the floor quality operations support for all areas and own the master batch record lifecycle processes including final review and approval.
• Providetechnical quality guidance as part of teams conducting investigations for complex manufacturing events.
• Reviewand approve complex deviations and/or Investigations that are site specific
• Activelysupport and/or lead preparation activities for Pre-approval Inspections and/or responses to observations.
• Work withproduct release teams to support issuance of drug substance Certificates of Conformance and any other disposition required activities.
• Manage CAPArecords and may be required to function as a CAPA manager for minor or major CAPA as needed
• Serve as QA Revieweror impact assessor for downstream purification change control records.
• Support and/or reviewvarious reports from quality systems
• Own various Qualityprocedures and ensure the systems/processes are deployed effectively

Requirements

• You will have excellent technical and regulatory understanding of the downstream drug substance purification processes.
• Strongexperience with various root cause analysis techniques such as 5-why Kepner-Tregoe force-field analysis DMAIC fault tree analysis.
• You willdemonstrate capability of interpreting and adapting various technical reports in support of Investigations/Deviations.
• Demonstratecapability of writing Investigation summaries in a concise and clear manner.
• Strong understandingof industry regulations such as CFR USP EP JP
• On the floorBiologics experience in a GMP environment required
• 7 years ofleadership/management experience in an Operations Manufacturing Technology or Technical Quality professional role.
• BS/BA Degree(Biological or Chemical Science Preferred) 9 years of relevant experience
• OR
• Masters Degree(Biological or Chemical Science) 8 years of relevant experience

Qualified candidates shouldAPPLY NOWfor 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!

Harish Yadav

Phone:

@

PAY RANGE AND BENEFITS:

Pay Range*:$80.00-$90.00 per hour.

*Pay range offered to a successful candidate will be based on several factors including the candidates 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 50000 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:

• Named One of Americas Best Employers for New Grads by Forbes (2024
• Named One of the Best Companies to Work for by U.S. News & World Report (Private Companies List 2024-2025)
• One of the Largest IT Staffing Firms in the US Ranked #3 by Staffing Industry Analysts (SIA 2024)
• One of the Largest Staffing Firms in the US Ranked #13 by Staffing Industry Analysts (SIA 2024; includes Innova Solutions Volt & HireGenics)
• Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)
• One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC 2024)
• AWS AdvancedTier Services Partner with 100 certifications

Website: Solutions offers a referral bonus for qualified Ambassadors who refer eligible referrals. Submit referrals at earn $250-$1000 per referral.

Innova Solutionsis 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 . 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.