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. Must Have: Minimum of 1 year of relevant labeling experience in a c GMP/FDA regulated environment preferred Some document management experience. Crystal reports and Bar Tender experience preferred. Experience Basic Qualifications: Minimum of 1 year of relevant labeling experience in a c GMP/FDA regulated environment. Some document management
experience. Crystal reports and Bar Tender experience preferred.
Strong communication and customer service skills. 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. Able to prioritize, manage time well, multi-task, and troubleshoot effectively. Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
Possess project management skills. Experience interacting with FDA or other regulatory agencies strongly preferred. Strong knowledge of c GMPs 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. Education: Bachelor's degree or Associate's Degree with 3+ Years of Experience in a c GMP/FDA Regulated Environment Vinay Bhatiya Associate- Recruitment PAY RANGE AND BENEFITS: Pay Range: $33.00 - $36.00 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 & shop 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) Clearly Rated 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 : / 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, interaction, age, physical or mental disability, veteran status, marital status, domestic partner status, interactionual 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 (770) 493-xyz X. Please indicate the specifics of the assistance needed.
Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (Hire Genics/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. Thanks, American Cybersystems, Inc is acting as an Employment Business in relation to this vacancy.
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