Scientist III

Eastridge Workforce Solutions is partnering with a pharmaceutical company in the city of Lynwood, CA, in its search for a Scientist III. Morning Shift -  Awesome benefits and room for growth offered. For immediate consideration, apply today.

JOB QUALIFICATIONS:

• BS/MS in Chemistry or related Scientific Discipline with a minimum of 8 years of pharmaceutical experience or equivalent combination of education and experience with testing Finished Products, Raw Materials, and Analytical Method Verification, Validations and Transfers. 
• Advanced technical skills in HPLC and GC required, including theoretical understanding of technique, troubleshooting, maintenance and consumable replacements.
• Advanced level of Chromatography Data Software (CDS) preferably Empower 3.
• Ability to enable quantification for assays and impurities calculations, create custom calculations, and design chromatographic reports in CDS. 
• Able to interpret data, including evaluation of stability testing for trends.
• Demonstrated use of analytical techniques in support of product development activities.
• Comprehensive knowledge of current Good Manufacturing Practices (cGMP), regulatory requirements, and ICH Guidelines 
• Understanding and adherence with CFR 21 Part 11 requirements. 
• Understanding, Knowledge, and performing of Raw Material qualifications of new incoming raw materials along with annual review requirements for existing Raw Materials. 
• Comprehension and ability to follow procedures of various pharmacopeias (USP, EP, JP). 
• Comprehension of regulated guidance (WHO, FCC, FDA, and ICH)
• Understanding and basic regulatory requirements and applies knowledge appropriately to activities.
• Demonstrated ability to work well in a fast-paced setting with teams.
• Self-starter with a strong work ethic 
• Must possess problem solving skills. 
• Must be able to operate with minimal supervision.
• Demonstrated ability to train and/or mentor employees.
• Excellent written and verbal communication skills

POSITION RESPONSIBILITIES:

• The Ability to analyze Finish Good Products and Raw Materials on HPLC, GC, FTIR, and Titrations (visual and potentiometric).
• Ability to manage multiple projects and accurately project realistic timelines. 
• Ability to Qualify Raw Materials by compendial testing procedures. 
• Authors Analytical Method Validation or Method Verification Protocols as guided by ICH, FDA, and cUSP.
• Responsible for analytical method validation/verification/transfer from clients or R&D to QC when assigned.
• Performs testing on raw material, in-process, & finished good samples when applicable.
• Documents all data in corresponding laboratory notebook and files documentation according to approved SOP and data integrity guidelines.
• Interface with contract labs regarding QC sample handling and reporting
• Evaluate and interpret the test results and other related technical documentation.
• Additional document writing includes, but not limited to, preparation and review of SOPs, STMs, failure investigation and process deviation report, stability study protocol/report, instrument qualification protocol/report and analytical technical transfer protocol/report 
• Other duties may be assigned as deemed appropriate by management.
• Mentors QC chemists and assists with training and professional development.
• Upholds all elements of data integrity.

PHYSICAL REQUIREMENTS:

• Employees are required to wear eye protection and lab coats while in the lab area.
• Work safely and follow all OSHA regulations and company safety policies and procedures.
• Ability to frequently lift and/or move up to 25 lb
• Ability to occasionally lift and/or move up to 35 lb
• Ability to regularly stand, sit and walk to perform tasks.

Benefits

401k, Health benefits, vacation, sick time and holiday pay 

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

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