QA Chemist

Industry

Health and Safety

Advert ID

USA_472510

Location

Irvine

Job Type

Contract

Hours

Full-Time

Salary Range

USD40-50/hr

No. of Openings

1

Branch Information

Talent Delivery and Solutions 100 Manpower Place WI Milwaukee , WI 53212

Branch Phone Number

-

Job Description

Job Summary



Position Summary



The Chemist is responsible for the preparation and review of assessments, protocols, reports, procedures, investigations, and other documents for the Quality departments within the client.



What's in it for you?

* Full time hours

* Competitive wage: $40 to $50 per hour

* Temp to hire opportunity

What is the job?

* Able to benchmark and apply industry best practices.

* Review, compare and update current documentation of processes and equipment functionality/design to comply with FDA's Code of Federal Regulations 21 CFR Parts 210 and 211.

* Perform and document investigations, CAPAs and effectiveness checks, as related to product testing.

* Organize, review and interpret statistical data and information from subject SMEs.

* Manage multiple projects simultaneously while interacting with various departments, vendors, contractors and clients.

* Problem Solving - Ability to solve problems by weighing all the variables to come up with a resolution

* Work on the Remediation and Product Impact Assessment teams and perform document control review.

* Participate on cross-functional teams to assist with the closure of chemistry related investigations.

* Review and draft investigations and risk assessments in support of chemistry quality compliance.

* Compile, review and interpret statistical data and information and present metrics.

* Perform administrative duties as required in support of chemistry related assessments and investigations.

Expertise: Knowledge & Skills

* Accuracy- Ability to perform work accurately and thoroughly.

* Analytical Skills - Ability to use thinking and reasoning to solve a problem.

* Communication, Oral & Written- Ability to communicate effectively with others using the spoken word and in composing clear and concise messages

* Conceptual Thinking - Ability to think in terms of abstract ideas.

* Customer Oriented- Ability to take care of the customers' needs while following company procedures.

* Decision Making -·Ability to make decisions for a course of action to be taken to address a specific issue.

* Detail Oriented -Ability to pay attention to the minute details of a project or task.

* Organized- Possessing the trait of being organized or following a systematic method of performing a task.

Qualifications:



Expertise: Qualifications - Experience/Training/Education/Etc



Required:

* Bachelor's degree in Biochemistry, Biology, Microbiology, Chemistry or related scientific field is strongly preferred with a minimum of 3-5 years' experience in a device, biopharmaceutical or biotechnology industry.

* Familiarity with ICH and FDA guidelines, GMP regulations and quality compliance requirements preferred.

* Must have excellent technical writing skills and graphics, editing, formatting and organization skills.

* Will need excellent scientific and technical writing abilities and advanced computer skills.

* Proficient in Microsoft Office Suite (MS Word and MS Excel)

* Must be able to read, write, speak the English language proficiently.



While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds