Posted in Other 8 days ago.
Innova Solutions has a client that is immediately hiring for a
Label Specialist
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.
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