82337
Please ONLY local candidates to Summit NJ
This position is 1st shift scheduled for Sun-Wed (6:30 am-4:30 pm)
TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.
Our client, a leading pharmaceutical company is hiring a QA Labeling Specialist.
MUST have:
- Requires Bachelor's Degree in Science (Biology, Chemistry, etc)
- Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment
- Some document management experience
- 1+ year of experience in Biopharma
- 1+ year of quality experience
- 1 years of labeling
- 3+ years with MS Office 365
Location: Summit NJ
Pay: $33-35/hour W2
Responsibilities:
- Responsible for supporting site Label Control activities in accordance with standards, procedures and Global cGMPs
- Functional responsibilities include performing in process and drug product label printing activities; ensuring accurate and timely issuance of labels for manufacturing and packaging
- Responsible for the establishment, maintenance and continuous improvement of the clinical and commercial label control process, procedures, and responsibilities for achieving quality policies and objectives
- Must have knowledge and experience with GMP, Quality, and compliance
- Able to write and review technical reports with clarity and brevity
- Crystal reports and BarTender experience preferred
- Good understanding of electronic document management systems
- Responsible for issuing clinical and commercial in-process and final product labels for labeling
- Coordinates with production teams to ensure timely issuance of labels
- Knowledge of quality processes, including label control and issuance, change control