As the primary Person in Plant near Lexington, KY, you will provide critical onsite oversight for small molecule drug product manufacturing, including granulation, compression, and coating operations. You will serve as the lead point of contact for external communications, managing exception handling and risk-based process assessments to ensure high-quality, on-time production. This role requires 7-10 years of experience in Quality or Technical roles, with a strong mastery of GMP and the ability to collaborate across global cross-functional teams.
location: Frankfort, Kentucky
job type: Contract
salary: $47.00 - 55.17 per hour
work hours: 8 to 4
education: Bachelors
responsibilities:
- Provides support to the primary point of contact for all communications pertaining to the drug product manufacturing at an external manufacturing site
- Serve as primary Person in Plant with responsibility to provide oversight during DP manufacturing
- Oversee and support exception management during manufacturing
- Provide technical support and oversight of SM DP manufacturing operations including granulation, blending, compression and coating.
- Participate in FMEA or other risk-based approaches to assess process performance
- Provide PM on site support to support on time manufacturing and respond to risk
- Act as main on site contact, escalating as appropriate and seeking cross functional alignment and clarifications as needed to ensure product quality, on time manufacturing and availability of product for forward processing.
qualifications:
Requires:
- B.Sc in related scientific discipline
- Minimum 7-10 years of experience in Quality / Technical role, PM experience is an advantage.
- Strong knowledge of Good Manufacturing Practices (GMP), specifically for small molecule drug product operations
- Ability to effectively manage time, multiple overlapping priorities and progress tasks to meet timeline in a fast pace/dynamic environment.
- Experience working cross-department with CMC, regulatory, MSAT and other quality functions across multiple countries / time zones
- Ability to evaluate and understands quality risk, including risk mitigation
Travel: Occasionally, as required
#LI-BM1
skills: Good Manufacturing Practices (GMP), Quality Assurance (QA), Quality Control (QC), Chemistry Manufacturing and Controls (CMC), Quality Management Systems (QMS)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
