Company

Alpha Consulting Corp.See more

addressAddressSummit, NJ
type Form of workContractor
CategoryInformation Technology

Job description

QA LABEL SPECIALIST- 3RD SHIFT
SUMMIT, NJ
 
Schedule: Wed-Sat 8:00 pm-6:00 am.
100% onsite.
Pay ranges between $40 - $46 per hour.
 
Required Skills: 
  • Bachelor's degree or equivalent degree.
  • Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment.
  • Some document management experience.
  • Crystal reports 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 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.
 
Project Description:
  • The Quality Assurance Document Control (QADC) Labeling Specialist supports the cGMP Document Control operations for the client site, including the 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.
  • 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.
 
Working Conditions (US Only):
  • Employees holding this position will be required to perform job-related duties supporting the Manufacturing Operations, related to batch documentation to support the various Manufacturing shifts.
  • Weekend and off-shift support may be required.
 
This 6+ month position starts ASAP.
 
Please E-MAIL your resume (attachment to email) with rate and availability to Supriya:
 
ALPHA'S REQUIREMENT #23-01210
W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
 
#LI-DNI
Refer code: 7468083. Alpha Consulting Corp. - The previous day - 2023-12-28 21:36

Alpha Consulting Corp.

Summit, NJ
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