Job Description:

• Position is scheduled for Wed-Sat 8:00 pm-6:00 am(3rd shift)

• This is 100% onsite position.

Job 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.

REQUIRED COMPETENCIES:

Knowledge, Skills, and Abilities:

Education: Bachelors 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.

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.

Contact:

Full Name: Akash Mehra

Email ID: akashm@askconsulting.com

Phone: 908-224-9613