QA CTO Label Specialist

Company: Innova
Location: Summit
Posted on: April 27, 2025

Job Description:

Innova Solutions has a client that is immediately hiring for a Label Specialist

Ensure you read the information regarding this opportunity thoroughly before making an application.

Position type: Full-time, contact
Location: Summit West, NJ
Duration: 06 Months.
Work scheduled for Wed-Sat (4pm- 2am) as 2nd shift


As a Label Specialist you will:
The Quality Assurance Label Control (QALC) Labeling Specialist supports the cGMP Label Control operations for the client site, including coordination, issuance, reconciliation, and management of production labels and records. To succeed in this role, you will have a strong attention to detail and an analytical mindset.

Qualifications:
--- Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment.
--- Some document management experience.
--- Crystal reports experience preferred .
--- Strong computer skills with MS Office (e.g., Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System).
--- Develop and improve label issuance processes to drive operational efficiency.
--- Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.
--- Possess project management skills.
--- Experience interacting with FDA or other regulatory agencies strongly preferred.
--- Strong knowledge of cGMPs and domestic regulatory requirements.
--- Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
--- Must be able to complete tasks independently and communicate with manager on decisions outside of established processes and the ability to build an internal network.

Primary responsibilities include:
--- Supports all activities for the Quality Assurance Label Control group.
--- Responsible for issuing clinical and commercial in-process and final product labels for labeling operations.
--- Responsible for ensuring accurate printed information on labels in compliance with health authority requirements.
--- Coordinates with production teams to ensure timely issuance of labels.
--- Performs training of label control and issuance requirements for internal personnel as needed.
--- Ensures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs as required.
--- Carries out plans and actions to support new drug product launches, new market and other quality management activities as assigned.
--- Provides support during internal and health authority inspections and audits of facility.
--- Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management.
--- Performs supplemental investigations/projects as required by Management.
--- Maintains knowledge of current GMPs and regulatory guidelines.
--- Weekend and off-shift support may be required.

Education:
--- Required Bachelor's degree with 2+ Years of Experience in a cGMP/FDA Regulated Environment

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
+1 470-226-3252
Sara.Almas@innovasolutions.com

PAY RANGE AND BENEFITS:
Pay Range*: Between $30.58 - $ 34.96per 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: 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, 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

Keywords: Innova, Union , QA CTO Label Specialist, Executive , Summit, New Jersey