Technical Manager, Clinical QA
American Cybersystems, Inc.

Job Info

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Innova Solutions is immediately hiring a Technical Manager, Clinical QA

Position type: Full-time Contract
Duration: 12 months and possibility for extension
Location: Novato California
As aTechnical Manager, Clinical QA, you will:
Hybrid role - 3 days a week onsite
Create revise and approve Phase Appropriate Quality Systems documentation Represent Clinical Quality Department in cross functions forums. Draft and approval of Quality Technical Agreements with CDMOs as required for internal support Provide quality oversight for internally manufactured early-stage products and starting materials Provide support to audits and inspections of CDMOs and internal manufacturing and testing organizations Provide quality oversight of one or more portions of operations including, but not limited to: Release clinical phase 1 and 2 materials ensuring compliance with phase appropriate lot release requirements. Review early-stage analytical testing in support of GLP and GMP clinical protocols and production activities. QA Issuance, Review and Approval of manufacturing production batch records in support of 300 BMK manufacturing operations Perform walkthroughs and other support activities of Analytical Science and Process Development to ensure compliance with applicable GMPs/GLPs. Review of GMP/GLP documentation from manufacturing and/or Analytical Operations, which can include logbooks, and test records. Perform QA Walkthroughs for 300 BMK manufacturing product changeovers Review and approval of SOP revisions initiated by manufacturing, Facilities and Engineering and Analytical support for 300 BMK Operations Management of quality system records including change requests, deviations and CAPA for the early-stage manufacturing and analytical science departments. Ensure manufacturing and adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations. Working knowledge of United States and European regulatory requirements, guidelines, and recommendations (additional jurisdictions a plus).

Skills: 7+ years experience in pharmaceutical Compliance, Engineering, Manufacturing, or Quality functions. Excellent interpersonal and communications skills required. Strong organizational and technical writing skills required. Computer literacy required, including Microsoft PowerPoint, Word, Excel. Demonstrates strong technical and analytical skills; provides assistance to solving training/employee issues. Results oriented; effectively manages a multitude of projects efficiently. Demonstrates excellent negotiation skills; develops effective and supportive relationships with the departments supported. Experience managing internal and external project stakeholders. Excellent written and verbal skills; ability to communicate effectively with all levels of the organization. Builds relationships with other functions, shares best practices, and solves shared problems. Demonstrates in-depth understanding and application of phase appropriate GMP principles, concepts, practices and standards in the US and internationally. Demonstrates substantial knowledge of industry best practices and trends. Positive, solution focused outlook on daily challenges.

Education: BA/BS from an accredited University/College 7+ years of experience with biotechnology, pharmaceuticals or human healthcare industries.

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

Thank you!

Vishnu Kaushik
Email: vishnu.kaushik@innovasolutions.com
Phone - 678-207-5230

PAY RANGE AND BENEFITS:
Pay Range*: $58 - $60 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.

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.

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