Senior QA Specialist at American Cybersystems, Inc. in Woburn, Massachusetts

Job Description:

Innova Solutions is immediately hiring for a Sr QA Specialist

Position type: 3+ month contract position

Location: Woburn, MA

Pay Range: $60/HR - $85/HR



The Senior QA Specialist will collaborate closely with the internal QC laboratories and other departments within the Ultragenyx network. We nurture and reinforce an active quality culture throughout the organization and provide the framework within which that work gets done.
We will assess your level based on your experience before moving forward with full panel interviews.
This is a Flex role that will typically require onsite work 3-4 days each week, or more depending on business needs.

Responsibilities

• Provide active support for QC site operations, inclusive of associated facilities, lab operations and IT operations.
• Partner with QC and support teams relative to quality/compliance aspects of changes and systems
• Provide review and approval of analytical method validation protocols, reports, and data packages.
• Generate and approve Certificates of Analysis (COAs) in LIMS to support batch release and regulatory filings.
• Provide Analytical QA approval of deviations and change controls.
• Support site/departmental inspection readiness programs, as needed.
• Provide quality system guidance and support for the QC laboratories, including data review processes, to ensure the health of the quality systems.
• Utilize risk management principles to continuously improve QC related processes and procedures.
Requirements

• Minimum B.S. degree in preferably microbiology, chemistry or biochemistry.
• 7 years of experience in biopharmaceutical or biotechnology based GMP clinical or commercial operations with a focus on Quality Control.
• Experience with both internal QC operations and external contract test lab operations is preferred.
• Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections.
• Experience leading continuous improvement efforts.


Candidates must have good communication skills and great attention to detail.
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!

Jeff.shay@innovasolutions.com

PAY RANGE AND BENEFITS:

Pay Range*: $60/HR - $85/HR

*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

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  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.