PDS Tech is seeking candidates for a Senior Site Specialist position in Thousand Oaks, CA
- Play a key role in a team of laboratory staff performing media and buffer operations for Research, Quality and Process Development
- Drive excellence in the Media Sciences program through right-the-first-time preparation of custom media formulations, compliance adherence, safe lab techniques, workload scheduling, and client satisfaction
- Champion innovation and practical process improvement in the laboratory
Specific responsibilities include but are not limited to:
- Maintain areas in high state of inspection preparedness.
- Maintains records to comply with regulatory requirements utilizing current Good Documentation Practices (GDP) and Standard Operating Procedures (SOP)
- Execute tasks associated with media and buffer preparation operations (e.g. complex calculations, aseptic technique, chemical inventory, troubleshooting, cell culture media prep, dilutions, microbial agar plates, pH titration, conductivity, osmolality adjustment, and GMP/GLP operations)
- Performs the weighing dispensing of raw materials for media and buffer prep, filtration, labeling and transfer of product.
- Perform verification/approval of peer calculations, technical documentation, and equipment logbooks
- Verification, calibration and use of common and specialized lab equipment
- Draft and revise more complex documents (e.g. media request procedures (MRPs), work instructions, GLP documents), May use specialized electronic systems
- Support implementation of continuous improvement projects.
- Perform other related duties as assigned by Supervisor
- Follows established safety and environmental guidelines and procedures for all work performed.
Basic skills and education needed
Bachelor’s Degree (BS/BA) from an accredited college or university with an emphasis in a scientific discipline (Biology, Biochemistry, Chemistry, Molecular biology or related field) and 1 year of laboratory experience.
Beyond that, the qualifications are:
- Experience in a laboratory setting; experience in GLP/GMP environment preferred
- Safety and the ability to maintain a compliant, highly effective and efficient product environment is critical.
- Skill in prioritizing assignments to complete work in a timely manner with deadlines, fluctuating workload, or lastminute changes.
- High level of attention to detail in both operations and documentation is required.
- Communicates effectively and ability to work in a team environment.
- Proven excellence in customer service
- Familiarity with Starlims (Laboratory Information management system) is a plus
Knowledge, Skills, Abilities
- Strong interpersonal and communications skills; written and oral
- Detail oriented and analytical; Decision making and problem-solving skills
- GMP/GLP compliance, audit critical records preferred
- Recognize & accurately report problems
- Strong working knowledge of Microsoft Office (Word, Excel, Visio, Outlook, Teams, PowerPoint)
- Experience writing laboratory procedures and work instructions.
- Organization and time management
- Working conditions include extensive walking/standing, ability to lift, push and pull up to 35 pounds consistently, and ability to work with carcinogenic, mutagenic, and irritant classified chemicals
- May need to provide weekend support