QA Associate (bioanalytical - pharma)
Company: Astrix Technology Group
Location: Hoffman Estates
Posted on: November 24, 2022
_this is a direct hire, on-site position. 1st shift M-F_
_\*\*looking for someone who is bringing direct relatable
Bioanalysis QA experience in a regulated GLP environment_
The Quality Assurance Associate is responsible for assisting with
the development, implementation and maintenance of a quality system
to support bioanalytical lab operations. Assist with the
development and execution of regulatory training for all employees
and for training on quality assurance policies, programs, and
initiatives. Ensure that documents are reviewed and processes
conducted and carried out in accordance with company quality
policies and procedures and are in compliance with GLP
requirements. Responsible for writing and reviewing SOPs and
quality documentation. Conduct in lab audits and review of
protocol, raw data and report supporting regulatory studies. Assist
with process and facility inspections.
* Serve as a source of quality assurance and GLP guidance to
* Assist with QAU administration.
* Participate in the maintenance of the document management
* Assist QA unit with awareness of compliance issues.
* Review site procedures and ensure consistency of content of
standards with GLP requirements. Present recommendations and
changes to management.
* Conduct and report inspections of study specific procedures and
* Reviews study plans, SOPs, raw data, methods and study reports;
ensures that no deviations from approved requirements were made
without proper authorization/documentation and were performed in
accordance with the GLP regulations (as applicable).
* Assist with conduct and reporting of Process and Facility
* Assist with training in GLP for Bioanalytical personnel.
* Participate in QA-Bioanalytical meetings.
* Additional duties as required and assigned.
* Knowledge of FDA regulations relating to GLP. Knowledge of
quality systems pertaining to contract research supporting
Pharmaceutical industry and good documentation practices within a
CRO, life science, pharmaceutical industry.
* Excellent computer skills; Word, Excel, PowerPoint and need to be
adept at learning new systems
* Highly organized; ability to prioritize and demonstrate attention
* Be pro-active and demonstrate initiative
* Good team player and experience of dealing with complex tasks
* Excellent customer service skills and ability to deal with people
at all levels
* Time-management skills are required, as well as the ability to
handle multiple projects
Job Type: Full-time
Pay: $45,000.00 - $65,000.00 per year
* 401(k) matching
* Dental insurance
* Flexible schedule
* Health insurance
* Paid time off
* Vision insurance
* 8 hour shift
* Day shift
* Monday to Friday
* No weekends
Ability to commute/relocate:
* Hoffman Estates, IL 60192: Reliably commute or planning to
relocate before starting work (Required)
* Bachelor's (Required)
* bioanalytical: 1 year (Preferred)
Work Location: One location%15196056%
Keywords: Astrix Technology Group, Hoffman Estates , QA Associate (bioanalytical - pharma), Other , Hoffman Estates, Illinois
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