Chemist - Analytical Services - Pharma Raw Materials SOP's FDA exp
Company: HireResources a Tailored Solutions Company (WO)
Location: Saint Petersburg
Posted on: June 7, 2021
Position Title: Chemist - Analytical
Reports to: Director of Analytical Services
Location: Largo, FL
Department: Analytical Services
- You will perform routine analytical testing of
pharmaceutical raw materials and finished products.
- You will assist in developing and validating analytical
methods for active pharmaceutical drug substances and drug
- You will provide analytical input in support of product
development to the formulation group.
- You will write and update SOPs, validation protocols,
reports, test procedures, and specifications.
- You will maintain laboratory notebooks and lab
instruments in compliance with internal SOPs and current IJSP, FDA
- You will communicate results in written and oral
Duties and Responsibilities:
- Ability to validate analytical methods for drug
substance and drug products as per approved
- Execute analytical test procedures for the analysis of
raw materials and finished products.
- Write and review analytical method validation
protocols, reports, and technical documents.
- Write and update Analytical SOPs.
- Provide analytical support for new product development
and participate in technical discussions with the formulation
group, CRO and CMO.
- Capable of self-scheduling of work
- Assures right-first-time execution of methods and
- Lead all analytical method transfer
- Provide support for ordering and maintaining inventory
of laboratory material and equipment.
- Participate in inter-department task
- Perform all other duties as assigned, or as business
Education and Experience:
- BS Degree in chemistry, biology, or other related
scientific discipline required.
- 3 to 5+ years of experience in the pharmaceutical
industry and has extensive knowledge of chromatographic
- Experience with pharmaceutical laboratory equipment
such as HPLCI I-JV, GCI Dissolution, IR, etc. is
- Experience in executing USP and EP test methodology is
- Ability to work effectively under pressure to meet
- Demonstrate critical thinking ability with experience
in conducting and writing laboratory investigations.
- Proficiency in word, excel, and pdf documents is a
plus. Excellent attention to details
- Excellent verbal and written communication
- Good knowledge of FDA guidelines, ICH, and related
- Basic understanding of pharmaceutical drug
- Ability to manage timelines and
- Ability to establish and maintain good working
Travel as part of your job duties, travel between buildings is
required on a routine basis. If applicable, you will be compensated
at the current IRS mileage reimbursement rate.
HireResources recruiters are not generalists; they are
specialists in their industries providing quick access to industry
top talent in select industry sectors. We speak your language and
understand the factors critical to your business. Each
HireResources Sector Team has a specialized target recruitment
function. In fact, if we do not have expertise in your industry, we
will let you know this up front.
HireResources was established in 2002, in 2015 we began a growth
phase by restructuring our core business, today, HireResources is a
fast growing Staffing & Recruitment platform headquartered in
Connecticut. HireResources is an open source staffing and
recruiting model giving flexibility and support to top executive
recruiters across the country. HireResources recruiters are
thoroughly vetted and are proven professionals in the recruiting
Keywords: HireResources a Tailored Solutions Company (WO), St. Petersburg , Chemist - Analytical Services - Pharma Raw Materials SOP's FDA exp, Other , Saint Petersburg, Florida
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