QA Auditor 1/2 - Quality Assurance

QA Auditor 1/2 - Quality Assurance

QA Auditor 1/2 - Quality Assurance
Location: Headquarters (Mattawan)


Description

QA Auditor 1/2 - Quality Assurance
About MPI Research:
MPI Research, with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries. Scientific knowledge and experience, integrity, trust, teamwork, and dedication to strong and enduring Sponsor relationships are the defining attributes that characterize MPI Research as a high-performance, high-quality organization that is committed to bringing safer and more effective products to the world. Learn more about how we can exceed your expectations at .
Responsibilities:

This position is responsible for performing independent, and at times subjective, assessments of protocols, laboratory procedures, data, and reports to determine the level of compliance with applicable domestic and foreign Good Laboratory Practices (GLP) Regulations, SOPs, and study protocols.

(Duties & Responsibilities – purpose of the function and result to be accomplished) include but are not limited to those listed:
· Communicates effectively with supervisors, colleagues, and Study Directors.
· Demonstrates commitment to quality.
· Effectively works in a team and demonstrates a commitment to achieving company goals.
· Efficiently prioritizes assigned daily workload and uses time productively.
· Punctual and reliable attendance according to MPI Research company policy.
· Adheres to safety procedures at all times.
· Audits study protocols for compliance with GLPs and departmental SOPs.
· Performs in-process audits according to protocols, GLPs, and departmental SOPs.
· Executes data and report audits according to protocols, GLPs, and departmental SOPs.
· Maintains accurate Quality Assurance (QA) reports of inspections.
· Attends all study and department meetings.
· Maintains the QA Master Schedule.

Qualifications:
· BA/BS in relevant field and 1 year of relevent experience; or
· HS/GED and 4 years of relevant regulatory auditing experience.
· Basic familiarity with Microsoft Office Suite.
· Computer skills, commensurate with Essential Functions and including ability to learn a validated
system.
· Ability to work extended hours beyond normal work schedule to include, but not limited to, evenings,
weekends, extended shifts and/or extra shifts, sometimes on short notice.
· Ability to work under specific time constraints.

Benefits at a Glance:
· MPI Research provides the following competitive benefits:
· Three choices of medical coverage, including prescription drug and vision coverage
· Two choices of dental coverage
· Medical and dependent pre-tax flexible spending accounts
· Paid time off bank and holidays
· Retirement savings plan – 401K plan with company matching on employee contributions
· Short/Long term disability plans, voluntary life insurance, and company paid life insurance
· Tuition reimbursement program
· Employee assistance program
· Employees at MPI Research also are given the opportunity to participate in company-sponsored events, wellness programs, self-directed work teams and open communications programs such as the All Employee Survey.