Part-Time GMP Quality / CAPA Specialist at Amerit Consulting Part-Time GMP Quality / CAPA Specialist at Amerit Consulting in Sandy, Utah Posted in 4 days ago.
Type:
part-time
Job Description:
OVERVIEW
About the job:
- NO Visa Sponsorship/ No H1Bs/ No C2Cs
- Our client, a US Fortune 250 company and a global medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished Part-Time GMP Quality / CAPA Specialist.
- JOB #: 3243
JOB TITLE
Part-Time GMP Quality / CAPA Specialist
•
JOB LOCATION
Onsite role at 9450 South State Street Sandy
UT 84070
•
JOB DURATION
Duration:
6-month contract (possible extension) •
WORK SCHEDULE
: Part-Time | 20-30 hours per week
Pay Rate:
$45.00/hr. - $47.00/hr.
POSITION SUMMARY
Seeking an experienced GMP Quality professional to support CAPA deliverables as part of a broader quality remediation initiative in a regulated environment. This role requires strong expertise in: GMP compliance Technical writing CAPA execution Investigation review Risk-based quality approaches The ideal candidate will independently drive inspection-ready documentation while partnering cross-functionally to ensure timely remediation activities and compliance with regulatory expectations
KEY RESPONSIBILITIES
Develop, manage, and execute CAPA records aligned with: Internal quality standards Regulatory expectations Perform technical writing and detailed review of: Investigations Protocols Reports Quality documentation Apply strong knowledge of: 21 CFR Part 211 GMP requirements Quality remediation practices Identify compliance risks, gaps, and remediation opportunities Collaborate with SMEs and cross-functional teams to: Drive CAPA closure Maintain project timelines Ensure audit readiness Support or author: Risk assessments Risk management documentation Utilize structured, science- and risk-based methodologies consistent with: ICH Q9 principles
JOB REQUIREMENTS
Education:
Bachelor's Degree require Experience supporting quality remediation initiatives Risk assessment and risk management experience Familiarity with: ICH Q9 Experience reviewing or authoring: Deviation investigations Root cause analyses Risk assessments Corrective action plans
Recruiter Contact Info Lalit Malgotra :
lalit.malgotra@ameritconsulting.com www.ameritconsulting.com I'd love to talk to you if you think this position is right up your alley, and assure prompt communication, whichever direction. If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you.
Company Overview:
Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally; as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients' businesses forward. Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, 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. Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.
