- We are a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
- A high-level of initiative, energy, and motivation are key role requirements, as well as organizational skills and the ability to motivate others.
- The Quality Associate 1 reports to the Quality Manager and is responsible for supporting Quality Systems related to operations, product specification change controls and batch release processes.
- This position requires interaction with multiple levels in Quality, Regulatory Affairs, Manufacturing, Supply Chain, Materials Management, and Contract Manufacturing Operations.
- Client's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
- These individuals build and maintain Client's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
- Create and/or revise product specification documents, following MAA, BLA, CTA, IND and/or IMPD filings, in Client's controlled document management system (Veeva).
- Initiate and set-up change control workflows for product specification revisions in Veeva and Client's quality management system.
- Coordinate Veeva change control workflows for review and approval of product specification revisions.
- Monitor and ensure document implementation timelines.
- Monitor backlog in associated trackers.
- Generate custom Certificates of Analysis to support lot release, new market applications, annual product reviews, and/or market renewals.
- Ensure all individual training and group-specific guidelines are kept current.
- Provide assistance with training new staff. EXPERIENCE Minimum 3-5 years of experience in a Quality, Compliance, and/or Regulatory setting. Strong attention to detail, organization and communication skills.
- Ability to maintain organization of a large volume of data in a systematic manner Proficiency with computer systems (Microsoft Office Suite).
- Proficiency with eQMS (Veeva), LIMS, Oracle EBS, eCDMS (Veeva) and Office365 preferred.
- 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
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External Quality Associate I - Novato, United States - Innova Solutions
![Innova Solutions background](https://contents.bebee.com/companies/us/innova-solutions/background-V271J.png)
Description
Innova Solutions is immediately hiring External Quality Associate I.
Position type: Fulltime - Contract
Duration: 13 Months
Location: Novato, CA
As External Quality Associate I, you will:
Job Description:
Hybrid - 2 days onsite (Tuesday anchor day and additional to be worked out with manager)
KEY RESPONSIBILITIES
Education: Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical engineering, chemical or biological sciences) is required. Advanced degree preferred.
Thank you
Pradip Joshi
Senior Associate, Recruitment
Phone:
PAY RANGE AND BENEFITS:
Pay Range*: $40-$43/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:
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.
* Create and/or revise product specification documents, following MAA, BLA, CTA, IND and/or IMPD filings, in BioMarin's controlled document management system (Veeva).
* Initiate and set-up change control workflows for product specification revisions in Veeva and BioMarin's quality management system.
* Coordinate Veeva change control workflows for review and approval of product specification revisions.
Education: Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical engineering, chemical or biological sciences) is required. Advanced degree preferred.
American Cybersystems, Inc is acting as an Employment Business in relation to this vacancy.