Quality Assurance Specialist
3 days ago
Job Title: Quality Assurance Specialist
Job Summary:
We are seeking a highly skilled Quality Assurance Specialist to join our team at Net2Source Inc. The successful candidate will be responsible for supporting the Quality Assurance Label Control group, ensuring accurate printed information on labels in compliance with health authority requirements.
Key Responsibilities:
- Support 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.
- Maintains knowledge of current GMPs and regulatory guidelines.
Requirements:
- Required Bachelor's degree with 2+ Years of Experience in a cGMP/FDA Regulated Environment.
- 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).
Working Conditions:
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. Occasional lifting of heavy weights up to 25 to 35 lbs.
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