QA Auditor 2/Senior QA Auditor - Quality Assurance
Company Name:
MPI Research
QA Auditor 2/Senior QA Auditor - 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 Quality Assurance (QA) functions that assure the GLP
compliance of MPI Research facilities & sites, including regulated studies & projects performed at MPI
Research, and reporting the results of these functions, including all findings & recommendations, to
management. MPI Research QA management has divided these responsibilities into three specialist
groups: study/ project team, facility/ compliance team, & Sponsor/ subcontractor team. Cross-utilization
may be executed as required & following appropriate training. The QA functions include, but are not
limited to, independent, and at times subjective, assessments of protocols, system validation records,
system use, laboratory procedures, equipment records, training records, data, and reports to determine the
level of compliance with applicable domestic and foreign Good Laboratory Practices (GLP) Regulations,
SOPs, policies (POL), and study protocols. It is also responsible for assisting management by
participating in the training of new auditors.
(Duties & Responsibilities - purpose of the function and result to be accomplished) could potentially include but are not limited to those listed:
Communicates effectively with supervisors, colleagues, Departmental Management, 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.
Audits study protocols for compliance with GLPs and departmental SOPs (study & project QA).
Performs in-process audits according to protocols, GLPs, and departmental SOPs.
Executes data and report audits according to protocols, GLPs, and departmental SOPs (study &
project QA).
Maintains accurate Quality Assurance (QA) reports of inspections.
Assists with the training and development of QA Auditors.
Attends all applicable study, project and department meetings.
Maintain the QA Master Schedule (study & project QA).
Audits system validation records and procedures for compliance with the GLPs, Validation Master
Plan, POLs, and departmental SOPs (facility & compliance QA).
Performs Process Qualification according to departmental SOPs, POLs, Appendices and Methods
(facility & compliance QA).
Performs inspections of designated laboratory areas and applicable 3rd party vendors (facility &
compliance QA).
Performs audits of equipment, departmental, and training records (facility & compliance QA).
Adheres to safety procedures at all times.
Punctual and reliable attendance according to MPI Research company policy.
Qualifications:
Bachelor's degree in relevant field and 3 years of relevent experience; or
HS/GED and 6 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:
Two 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.
Location: Headquarters (Mattawan)Estimated Salary: $20 to $28 per hour based on qualifications.
MPI Research
QA Auditor 2/Senior QA Auditor - 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 Quality Assurance (QA) functions that assure the GLP
compliance of MPI Research facilities & sites, including regulated studies & projects performed at MPI
Research, and reporting the results of these functions, including all findings & recommendations, to
management. MPI Research QA management has divided these responsibilities into three specialist
groups: study/ project team, facility/ compliance team, & Sponsor/ subcontractor team. Cross-utilization
may be executed as required & following appropriate training. The QA functions include, but are not
limited to, independent, and at times subjective, assessments of protocols, system validation records,
system use, laboratory procedures, equipment records, training records, data, and reports to determine the
level of compliance with applicable domestic and foreign Good Laboratory Practices (GLP) Regulations,
SOPs, policies (POL), and study protocols. It is also responsible for assisting management by
participating in the training of new auditors.
(Duties & Responsibilities - purpose of the function and result to be accomplished) could potentially include but are not limited to those listed:
Communicates effectively with supervisors, colleagues, Departmental Management, 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.
Audits study protocols for compliance with GLPs and departmental SOPs (study & project QA).
Performs in-process audits according to protocols, GLPs, and departmental SOPs.
Executes data and report audits according to protocols, GLPs, and departmental SOPs (study &
project QA).
Maintains accurate Quality Assurance (QA) reports of inspections.
Assists with the training and development of QA Auditors.
Attends all applicable study, project and department meetings.
Maintain the QA Master Schedule (study & project QA).
Audits system validation records and procedures for compliance with the GLPs, Validation Master
Plan, POLs, and departmental SOPs (facility & compliance QA).
Performs Process Qualification according to departmental SOPs, POLs, Appendices and Methods
(facility & compliance QA).
Performs inspections of designated laboratory areas and applicable 3rd party vendors (facility &
compliance QA).
Performs audits of equipment, departmental, and training records (facility & compliance QA).
Adheres to safety procedures at all times.
Punctual and reliable attendance according to MPI Research company policy.
Qualifications:
Bachelor's degree in relevant field and 3 years of relevent experience; or
HS/GED and 6 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:
Two 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.
Location: Headquarters (Mattawan)Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
