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location: San Diego, California
job type: Contract
salary: $35.00 - 44.25 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- As an Analytical Chemistry Scientist II at Company's Reagent Development Services - Analytical Method Development and Transfer Group, you will work in a dynamic, team-oriented environment, collaborating with internal and external partners to develop, validate and, transfer analytical methods to support formulation development, stability testing, and quality control testing of raw materials, intermediates, and final products in accordance with project timelines. This position requires strong knowledge of chromatographic, spectroscopic and enzymology assay techniques as well as hands-on experience in development of high quality and robustness analytical methods.
- Plan and execute various laboratory experiments under general direction.
- Develop, validate and transfer test methods according to Good Manufacturing Practice (GMP) and/or regulatory requirements (FDA 21 CFR Part 11 and ISO).
- Prioritize assignments. Deliver results within project timelines.
- Perform data analysis and troubleshoot aberrant results and draw sound conclusions.
- Prepare study protocols and reports. Write assay work instructions.
- Observe and comply with GMP and Good Documentation Practice (GDP).
- Work with all members of staff to maintain and develop the positive progressive culture.
- Undertake other duties as assigned by manager.
qualifications:
- B.S./M.S./Ph.D in Analytical Chemistry, Chemistry, Biochemistry, Molecular Biology, or similar scientific fields.
- BS with Minimum 2 years of experience in analytical method development, qualification, validation and transfer using various analytical techniques such as HPLC, LC-MS, CE, UV, NMR, Fluorescence plate readers, enzyme activity assays, etc.
- Ability to perform collaborative experiments with team members across multiple disciplines.
- Highly proficient, productive, and effective in the lab. Excellent lab organization and documentation skills.
- Knowledge and working application of method validation principles for regulated industries including FDA cGMP; ICH/USP guidelines, ANSI/ISO/ASQC.
- Excellent verbal/written communication and interpersonal skills. Flexible and adaptable.
- Must be analytical, detail-oriented, organized, takes initiative, and self-motivated.
- Hands on experience with Next Gen Sequencing (NGS) technologies a plus.
- All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
skills: Molecular Biology, HPLC, FDA, Analytical Chemistry, Chemistry, Chromatography, GLP (Good Laboratory Practice), ICH Regulations, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
