Job Title:
Production Chemist
Location: Pamona CA
Duration: 12 months
The position of Production Chemist I is within our Toxicology Business Unit located in California.
Under close supervision, this position is responsible for a variety of manufacturing support functions involving the operation of lab equipment and conduct of procedures/tasks according to established GMP, under the direction of senior staff.
This job description will be reviewed periodically and is subject to change by management.
Responsibilities:
- Adhere to laboratory safety rules
- Read and understand Standard Operating Procedures (SOPs) related to job functions
- Perform the daily, weekly, monthly, and yearly maintenance of laboratory equipment and maintain maintenance logbooks
- Manufacture all products via Batch Records and/or Standard Operation Procedures (SOPs) following the guidelines for Good Manufacturing Practice (GMP) in accordance with the Quality System
- Manufacture antibody solutions, drug positive solutions, enzyme-conjugate solutions, EIA calibrators and controls and reagents
- Perform a variety of analytical EIA in-process testing
- Perform daily temperature monitoring
- Carry out production tasks in support of manufacturing goals and objectives
- Participates in Lean Activities
- Operate laboratory equipment safely, as trained and directed, in accordance with established practices
- Maintain records and notebooks as directed in a neat, thorough and accurate manner. Perform required data entry on company planning and materials management system. Report results to supervisor
- Maintain a neat and organized workplace. Ensure materials are appropriately labeled, approved for use and in enough quantity to complete required tasks
- Recommend and participate in document revisions to ensure accurate BOM's process descriptions
- Recommend and participate in document revisions to ensure accurate NCMR and deviations
- Perform complex simple formulations, component and material evaluations, equipment calibrations and maintenance
- Ability to work overtime and/or on weekends
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices; build productive internal/external working relationships
- Carries out duties in compliance with established business policies
- Other duties as assigned, according to the changing needs of the business
Minimum qualifications | Education/experience:
- BA or BS in Chemistry or Biological Sciences
- 0 to 2 years' experience in laboratory environment
- Strong verbal and written communication skills
- Ability to follow detailed instructions, maintains accurate records and notes, and carries out assignments in a thorough, conscientious fashion while adhering to safe laboratory practices.
Preferred qualifications:
- Knowledge of a variety of lab equipment and their operation is preferred
- Demonstrate problem-solving and troubleshooting skills
- Process orientated, Logical, analytical, meticulous, highly organized and able to analyze data & implement solutions
- Ability to work in a team environment while satisfying individual responsibilities and objectives.
- Knowledge and ability to use MS Office and other manufacturing systems
- Adaptable and willing to take on multiple new tasks and responsibilities
- Independent collaborative self-starter with the ability to make appropriate quality-related decisions in real time
Competencies:
- Attention to detail
- Work in a team environment
- *Driven for results
Additional Skills Needed
- This Entry Level Chemist Role is for the Bulk Reagent Formulation. (Manufacturing)
- Recent or new grads with lab experience would work fine in role. It will be better if they come with GMP experience but if not can be taught onsite
- Batch records. SOPs.
- Science BS -
- Is a master degree considered overqualified? Yes this is an entry level position.
- What types of projects and test will the worker be doing.
- Making reagents for ELISA, HEIA, and Calibrators and Controls. Antibody purification.
- Testing antibodies, antigens.
- Making reagents and testing them.
- Interacting with quality control and quality assurance team.
- Preferably 1 to 2.
- Experience in medical device, leadership and good writing skills.
|