**12 months long project with possibilities of extension**
Pay - $25/hr - $27/hr
- Education: Bachelor’s Degree in Biology, Biochemistry, Chemistry or relevant discipline.
- 2 years cGMP experience in a sterile, bulk or finished pharmaceutical environment. – Co-op experience okay
- Electronic batch record familiarity/experience
- Data analysis/analytical experience
- Computer literacy in MS Office, Word, Outlook, Excel.
- Familiarity with cGMPs in pharmaceutical industry.
Preffered Experience and Skill:
- Experience with LIMS/GLIMS
- Knowledge of Veeva Vault, Track Wise would be helpful.
- Experience with formal problem solving techniques, such as root cause analysis (RCA), failure mode effects analysis and/or Lean Six Sigma Tools.
- Technical writing experience related to investigations into manufacturing process variation
- Willingness to cover off-shift
- Manufacturing plant experience in operational capacity
- Experience working in a Union environment
- Experience working in SAP or other Enterprise Software
- Knowledge of Code of Federal Regulations.
- Quality experience • Experience with CAPA process
- The Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement.
- We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.
- Our West Point site is seeking 2 Operations Specialists to join our growing team of 15 for an exciting opportunity on first shift.
- Operations provides support to manufacturing operation organizations.
- This high impact role assures that products manufactured comply with cGMPs, operating procedures and other applicable regulations. The support focuses on management of the shop floor compliance and implementation of lean manufacturing initiatives aligned with department goals.
- You will be supporting day-to-day operations and compliance tasks and bridging some of the gaps that the shift supervisors cannot.
- You will be more pointed towards documentation, reviewing batch records, compiling CSR data, executing Environmental Monitoring, practical tests and other documentation and data against batch records and submitting to Quality team, per procedure.
- You will be fielding any Quality exceptions, pulling together attachments, helping to investigate CAPA reviews, understanding and coordinating corrections and working with shift managers to set up corrections.
To apply for this position, click on apply and send in your resume along with your contact info. For any further queries please feel free to contact:
cGMP experience,pharmaceutical environment,sterile, bulk