GxP Quality Consultant
Apply NowCompany: Pace
Location: Frederick, MD 21702
Description:
Make an impact.
At Pace, we're committed to continuously moving science forward; to innovate and advance sustainable practices that improve the health and safety of our communities and lives. Ask any of us, and you'll hear the same thing repeated again and again: we work here because what we do positively impacts the world.
Find your place at Pace
Join us as a Senior Consultant GxP Compliance Quality Assurance, where you'll put your love of science to work in the Scientific Insourcing Services department.
As a Senior Consultant, you will provide our clients Quality Assurance support and guidance on GxP matters as it pertains to their drug development programs.
Note : This is position is hybrid and will require up to 20% travel, and some occasional weekend work
What you'll do
#LI-Hybrid
Benefits
80 hrs of paid vacation per year, 7 paid holidays per year, 2 floating holidays per year (prorated based on start date), 40 hrs paid sick time per year, paid bereavement leave (days based on relation to the employee), 8 hrs paid volunteer time per year, medical, dental, vision, voluntary short-term disability, long-term disability, life insurance, voluntary supplemental life insurance, traditional 401k and ROTH 401k with a company match, HSA, FSA, employee referral bonus, employee assistance program, tuition reimbursement program, employee recognition program, voluntary ID theft coverage, voluntary legal coverage, voluntary accident insurance, voluntary hospital indemnity insurance, and voluntary critical illness insurance.
Equal Opportunity Employer
Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Work Schedule
M-F, 8-5 with flexibility some occasional weekend support
At Pace, we're committed to continuously moving science forward; to innovate and advance sustainable practices that improve the health and safety of our communities and lives. Ask any of us, and you'll hear the same thing repeated again and again: we work here because what we do positively impacts the world.
Find your place at Pace
Join us as a Senior Consultant GxP Compliance Quality Assurance, where you'll put your love of science to work in the Scientific Insourcing Services department.
As a Senior Consultant, you will provide our clients Quality Assurance support and guidance on GxP matters as it pertains to their drug development programs.
Note : This is position is hybrid and will require up to 20% travel, and some occasional weekend work
What you'll do
- Establish a Quality Management Program System (QMS)
- Development and revision of SOPs as needed
- Management of Client QMS including deviations, CAPAs, OOS, etc
- Perform GxP audits (Internal, External, Phase)
- Review GxP documentation
- Advise on GMP/GLP quality matters as needed
- Bachelor's Degree Biology, Chemistry or equivalent and 10+ years of QA experience
- cGMP and GLP experience required
- Experience with in vivo and in vitro studies, preferred
- Strong verbal and written communication skills
- Detail oriented and self-motivated
- Ability to work independently on multiple simultaneous projects
#LI-Hybrid
Benefits
80 hrs of paid vacation per year, 7 paid holidays per year, 2 floating holidays per year (prorated based on start date), 40 hrs paid sick time per year, paid bereavement leave (days based on relation to the employee), 8 hrs paid volunteer time per year, medical, dental, vision, voluntary short-term disability, long-term disability, life insurance, voluntary supplemental life insurance, traditional 401k and ROTH 401k with a company match, HSA, FSA, employee referral bonus, employee assistance program, tuition reimbursement program, employee recognition program, voluntary ID theft coverage, voluntary legal coverage, voluntary accident insurance, voluntary hospital indemnity insurance, and voluntary critical illness insurance.
Equal Opportunity Employer
Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Work Schedule
M-F, 8-5 with flexibility some occasional weekend support