Quality Specialist - I (Assistant)
American Cybersystems, Inc.

Job Info

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A client of Innova Solutions is immediately hiring for a Quality Specialist

Position type: Full-time Contract, potential contract to hire
Duration: 12 months
Location: Elkhorn, NE 68022 USA
Position: Quality Specialist

As a Quality Specialist , your responsibilities:.
Must haves:

• Somebody who has worked in a regulated industry (FDA/USDA)
• GMP industry.(Pharma/Vaccine manufacturing/Animal health products or Medical device)
• Experience with change control and change management expertise.
• From quality assurance perspective process lot of change processes within packaging.
• Regulated packaging experience.
• QMS expertise (Trackwise or SAP or Reliance)

Position Description:

• This role will primarily support Manufacturing Operations and will serve as the primary Quality Assurance for the PS&S (Packaging Simplification and Sustainability) Initiative at the Elkhorn, NE Site.
• This team member will provide guidance to the PS&S team from a quality compliance perspective having knowledge of local and global Animal Health standards, USDA regulations, and cGMP generally.
• This position will serve in the Quality role in Reliance quality systems, Deviation Management and Change Controls for this Packaging Initiative.
• This team member will also be expected to regularly spend time within the department to learn processes, evaluate compliance and build relationships of trust with production operators and management.
• They will also assist with other day-to-day packaging related quality questions and inquiries.
• An additional part of the role will be to oversee the update and review SOP's (Standard Operating Procedures) that relate to the Packaging department.
• Additionally, this role will be occasionally assigned short term tasks and projects with varying degrees of urgency and difficulty and thus organization, critical thinking and creativity are necessary attributes for this role.
• A successful candidate will navigate the various perspectives of Planning, QA and Production utilizing Leadership Behaviors and principals of Inclusion, while holding Safety and Quality as primary values.

Additional duties will include the following:

• Assist the local QA teams with other short-term projects and/or site initiatives
• Serve as the back-up for other team members when not in the office.
• Key participant in Quality Compliance Inspections from off-site entities.
• Other tasks as assigned by QA Manager and Quality Director

Qualifications:

• High School with at least 3 years of relevant experience or
• Associates Degree/Bachelor's degree/Master's degree with 1+ year of relevant experience in a regulated industry.

Required Experience and Skills:

• Minimum of 2 years of Quality experience in a regulated industry.
• Strong communication skills both written and verbal.
• Experience with investigations, risk assessment, and regulatory inspections.
• Skilled in technical writing.
• Candidates have experience in QMS like SAP, Trackwise and Reliance or similar quality system.

Preferred Experience and Skills:

• Familiarity and/or experience with vaccine manufacturing and specifically packaging.
• Familiarity and/or experience with USDA regulations and inspections, and knowledge regarding the Animal Health Quality Manual.
• Project Management 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.
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!
Sonam Yadav
PHONE: (+1) 585-625-4180
EMAIL: sonam.yadav@innovasolutions.com

PAY RANGE AND BENEFITS:

Pay Range*: $35/hr to $40/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 centres 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 field

Recent Recognitions:

• Named One of America's 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 Advanced Tier Services Partner with 100+ certifications

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, colour, 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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