Analytical Scientist

Job DescriptionJob DescriptionPosition Summary:
This position conducts tests to determine quality of raw materials, bulk intermediate, finished products, and cleaning verification/validation samples and ensure compliance with established standards. Lead method development and validation. Conducts routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability
samples.  Leads laboratory investigations and writes laboratory protocols and reports.  This position may be called on to interact with clients on laboratory activities such as method development, data interpretation, investigations.

Essential Job Functions:

• Assists the Manager, Analytical Laboratory Services in the development and maintenance of the analytical laboratory and its practices and procedures.
• Performs various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods.
• Write complex analytical development and validation protocols.
• Develops, conducts, and validates various chemical assays.
• Develops, evaluates, and validates analytical methods for activities such as cleaning verification via HPLC.
• Collects and analyzes routine equipment cleaning verification/validation samples.
• Complies, interprets, and documents data from analytical tests.
• Troubleshoots analytical methods and equipment.
• Prepares Certificates of Analysis and authors complex analytical reports.
• Prepares and maintains raw data for review.
• Documents analyses in laboratory notebook, worksheets, or production batch records as applicable.
• Peer-reviews laboratory records.
• Communicates quality or compliance concerns to Line Manager and Senior Management with urgency as applicable.
• Leads Out-of-Specification (OOS) or Out-of-Tolerance (OOT) laboratory investigations and communicate findings to Quality and Operations per internal SOPs.
• Supports environmental monitoring activities as required.
• Complies with Standard Operating Procedures (SOPs), cGMPs, and other regulatory standards as applicable.
• Performs other duties as assigned.

Qualifications:

• Bachelor’s degree in Chemistry or relevant field with a minimum of 5 years of analytical laboratory experience - internships and college work can be included in this
• Minimum 2 years of experience with HPLC method development.
• Familiar with cGMPs, EU, 21 CFR Part 210, 211, and 820, ISO and ICH guidelines.
• Strong background and understanding of USP, EP, other pharmacopeia.
• Specific experience in either Dissolution testing or Aerosol testing.
• Excellent written and verbal communication skills with ability to give internal and external presentations.
• Hands-on skilled coordination and dexterity and attention to detail
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) or related software.
• Excellent organizational and communication skills.
• Read and interpret documents such as standard operating procedures, manuals, experimental protocols, and analytical methods.
• Legible Handwriting
• Communicate clearly in writing and orally including in the creation of standard operating procedures and work instructions.
• Communicate with clients on topics such as method development, data interpretation, and investigations.
• Apply concepts of basic arithmetic such as addition, subtraction, fractions, percentages, ratios and proportions to practical solutions.

Pay Details: $50.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

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