What are the responsibilities and job description for the Operations Specialist position at TekWissen LLC?
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. This Client's mission is to discover and deliver innovation medicines and solutions that address complex health issues and enhance people's lives.
Position: Operations Specialist
Location: Irvine, CA, 92612
Duration: 12 Months
Job Type: Contract
Work Type: Onsite
Shift: 8-4 and some overtime is required
Job Description:
Purpose:
- Performs functions associated with cGMP biologics manufacturing operations within the production facility, including working with other operations personnel in equipment set-up and batch processing.
- Uses sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment.
- Works with Quality, Maintenance, Warehouse, Documentation and Materials Management departments to execute the production plan.
- Assists in developing procedures to control or modify the manufacturing process.
Responsibilities
- Cell culture (from vial thaw to production scale).
- Column chromatography.
- Tangential flow filtration
- Sampling of in process and raw materials.
- Running glass washer / autoclave.
- Buffer / media preparation.
- Equipment preparation (CIP / SIP).
- Maintaining inventory levels.
Qualification:
- Bachelor's Degree or equivalent required.
- At least 2-5 years relevant experience with good writing skills and computer skills.
- Working knowledge of media/buffer preparation, cell culture or purification of biological drugs is required.
- Working knowledge of safety, quality systems, and cGMPs is required
- Completes tasks in resourceful and effective ways.
- Applies knowledge, experience, and technical skills to understand production objectives, to provide support to production initiatives, to execute procedures efficiently and compliantly, and use standard practices to ensure inter-group consistency.
- Works on problems of moderate complexity, where analysis of situations requires evaluation of several factors.
- Works with management and senior staff to determine appropriate course of action within defined procedures.
- Coordinates activities of sub-group and actively works with other sub-groups. Frequently interacts with supervisor
What are the top 3-5 skills, experience or education required for this position: Yes,
- Bachelors degree and At least 2 years of experience in Manufacturing Operations
- Ability to manage multiple priorities in a constantly changing and challenging environment.
- Knowledge of Good Manufacturing Practices (GMP)
- Knowledge of media/buffer preparation, cell culture or purification of biological drugs
- Ability to operate specialized manufacturing equipment as appropriate.
- Ability to communicate issues to appropriate operations, engineering and mechanical team required.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
