• Job Type:Contract

Posted 6 days ago

Job Description:

Position is scheduled for Wed-Sat 8:00 pm-6:00 am(3rd shift)
This is 100% onsite position.
Duration: 6 months(high possibility of extension for right candidate)

• 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.

REQUIRED COMPETENCIES:
Knowledge, Skills, and Abilities:

Education: Bachelor’s degree or equivalent

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 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.

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.