Analytical Scientist
Job
Actalent
East Windsor, NJ (In Person)
$88,400 Salary, Full-Time
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Job Description
Job Title:
Analytical Scientist Job Description This position supports R D scientists and conducts tests to determine the quality of raw materials, bulk intermediates, finished products, and cleaning verification/validation samples to ensure compliance with established standards. The role may involve method development and validation, and conducting routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples. Responsibilities Support the Analytical Laboratory Services in the development and maintenance of the analytical laboratory and its practices and procedures. Perform various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods. Develop, conduct, and validate various chemical assays. Develop, evaluate, and validate analytical methods for activities such as cleaning verification via HPLC. Collect and analyze routine equipment cleaning verification/validation samples. Compile, interpret, and document data from analytical tests. Troubleshoot analytical methods and equipment. Prepare Certificates of Analysis and analytical reports. Prepare and maintain raw data for review. Document analyses in laboratory notebook, worksheets, or production batch records as applicable. Peer-review laboratory records. Communicate quality or compliance concerns to Line Manager and Senior Management with urgency as applicable. Support Out-of-Specification (OOS) or Out-of-Tolerance (OOT) laboratory investigations and communicate findings to Quality and Operations per internal SOPs. Support environmental monitoring activities as required. Comply with Standard Operating Procedures (SOPs), cGMPs, and other regulatory standards as applicable. Perform other duties as assigned. Essential Skills Bachelor's Degree in Chemistry or a relevant field with a minimum of 3 years of analytical laboratory experience. At least 3 years of experience with HPLC method development. Familiarity with cGMPs, EU, 21 CFR Part 210, 211, and 820, ISO and ICH guidelines. Strong background and understanding of USP, EP, and other pharmacopeia. Specific experience in either Dissolution testing or Aerosol testing. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) or related software. Excellent organizational and communication skills. Additional Skills & Qualifications Excellent written and verbal communication skills with the ability to give internal and external presentations. Hands-on skilled coordination and dexterity with attention to detail. Ability to read and interpret documents such as standard operating procedures, manuals, experimental protocols, and analytical methods. Legible handwriting. Ability to communicate clearly in writing and orally including in the creation of standard operating procedures and work instructions. Capability to communicate with clients on topics such as method development, data interpretation, and investigations. Ability to apply concepts of basic arithmetic such as addition, subtraction, fractions, percentages, ratios, and proportions to practical solutions. Work Environment This role is based in a brand-new facility with state-of-the-art equipment. The work environment is fast-paced, supporting the growth of a dynamic CMO. The team is expanding with the construction of an additional lab. Job Type & Location This is a Contract to Hire position based out of East Windsor, NJ. Pay and Benefits The pay range for this position is $40.00 - $45.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in East Windsor,NJ.
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