Innova Solutions

Innova Solutions is immediately hiring a Field Quality Assurance Specialist.

Job Title: Field Quality Assurance Specialist

Position type: Full-time Contract

Duration: 12 Months

Location: Devens, MA Onsite

Work Schedule: Mon - Fri, 2PM - 10PM EST

As a Field Quality Assurance Specialist you will:

Field QA Specialist is responsible for quality activities for the Single Use Facility in accordance with Client policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues. The Contractor Field QA Specialist role is stationed in Devens, MA and reports to the Senior Manager of QA Operations for the Devens SUF.

Responsibilities

• Perform QA on the floor activities.
• Ensure manufacturing compliance with applicable procedures and batch records.
• Perform real time review of manufacturing batch records.
• Review manufacturing shop floor documentation.

Education Requirements

• High School Degree required
• Relevant college or university degree preferred.
• Minimum 4 years relevant work experience, with experience in a Quality Assurance role.

Qualifications Required

• Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Develops and revises procedures.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Knowledge of US and global cGMP requirements.

Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.

• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

Training schedule

This is 8 - 10 weeks on 1st shift which is 7AM - 3:30PM Mon - Fri

candidates should be able to work this schedule for this time period, and then be available to move to the 2nd shift work schedule.

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!

Sara Almas

Team Recruitment

Sara.Almas@innovasolutions.com

PAY RANGE AND BENEFITS:

Pay range: $55.00 -$ 59.44 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.

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

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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