- Expiry Date: 08 October 2023
- Referral: firstname.lastname@example.org
"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".
Schedule: Wed-Sat 8:00 pm-6:00 am (3rd shift)
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.
Bachelor's degree or equivalent degree
Experience Basic Qualifications:
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
Duties and Responsibilities:
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 markets, and other quality management activities as assigned.
Provides support during internal and health authority inspections and audits of the 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.
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.