Analytical Chemist
TekWissen ® · Fremont, CA · 5 days ago
On-siteAnalyst$22–$28/hrContract
Responsibilities
- Maintain and analyze lot history records to identify trends and discrepancies.
- Support process improvement initiatives, 5S activities, and laboratory organization projects.
- Initiate and support investigations involving non-conformances, CAPAs, and variances.
- Communicate production issues and project updates to supervisors and management.
- Perform additional duties as assigned.
Requirements
- Bachelor's degree in Chemistry, Biochemistry, or a related scientific discipline; equivalent education and experience may be considered.
- Minimum 1 year of laboratory or manufacturing experience preferred.
- Experience working in a cGMP-regulated manufacturing or laboratory environment.
- Knowledge of Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
- Experience performing laboratory techniques including pipetting, weighing, mixing, filtration, and chemical handling.
- Experience with in-process testing and clinical analyzers preferred.
- Familiarity with hazardous chemical handling and laboratory safety procedures.
- Experience working with human source materials preferred.
- Knowledge of Quality System Regulations (QSR), ISO 13485, and IVD regulations preferred.
- Experience supporting quality investigations, including CAPAs, non-conformances, and variances.
- Experience reviewing batch records and maintaining accurate documentation.
- Experience maintaining and troubleshooting laboratory equipment.
- Strong analytical and problem-solving skills.
- Excellent attention to detail and organizational skills.
- Ability to prioritize multiple tasks in a fast-paced environment.
- Self-motivated with the ability to work independently and as part of a team.
- Strong verbal and written communication skills.
- Ability to comply with controlled substance handling requirements and laboratory safety protocols.
Qualifications
- Ability to routinely lift up to 25 lbs. and occasionally lift up to 50 lbs.
Skills
- Laboratory experience
- Strong documentation skills
- Ability to work safely with hazardous chemicals and controlled substances
Benefits
N/A
Pay
$22 to $28 per hour
Schedule
Monday to Friday from 09:00 AM to 05:00 PM