NCBiotech Jobs Board ● Connecting North Carolina's life science employers and workforce.


General Information

Job title:
Job location:
Durham, NC  27713 United States
Requisition code:
Date posted:
Job category:
Agricultural Biotechnology
Quality Control
Employment type:
Full time

Job Description

Experienced Under the supervision of the Director of Quality Control, the candidate is responsible for the establishment of cGMP compliant quality control programs supporting manufacturing/laboratory operations. Responsibilities include the following:

• Lead the establishment and management of quality control program standards, procedures, and services for Quality Control Support program
• Supervise QC Specialists engaged in laboratory operations for sample collection, storage, testing, and documentation activities supporting raw material analysis, stability monitoring, and sample coordination to ensure high productivity, technical integrity, and compliance with GMP laboratory standards
• Work according to Medicago procedures and policies with external customers (Manufacturing, QA, Validation, etc.) to maintain a GMP compliant laboratory
• Manage department resources and projects to support the testing of raw materials, stability monitoring, and sample coordination
• Provide timely and accurate reports and assessments of routine activities and other assigned project(s) status to the Director of Quality Control
• Adhere to Medicago operational and financial objectives by estimating resource and cost requirements; participating in the preparation of an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions
• Accomplishes Quality Control human resource objectives by recruiting, selecting, orienting, training, assigning, scheduling, coaching, counseling, and disciplining employees; communicating job expectations; planning, monitoring, appraising, and reviewing job contributions

Job Requirements

• overseeing and leading a team of scientists to meet a common goal while adhering to all associated timelines for multiple projects
• Competent in establishing and managing cGMP compliant quality control and analytical programs including scientific/technical report writing the supporting documentation for laboratory operations and training activities
• Knowledge of quality/regulatory systems, ability to evaluate records, processes, procedures, and practices for conformance to cGMP requirements
• Ability to function independently to perform routine organization and analysis of methods/data, critical decision making, and communicate/interact with all levels of management to meet critical deadlines/objectives
• Must be well organized, a self-starter, results oriented individual with the ability to multitask in a fast paced team environment with attention to detail and good documentation practice
• Experience with enterprise applications (example: LIMS, Trackwise, Documentum, SAP) preferred

• Requires a Bachelor’s or Master’s degree in science and 8 or more years of QC experience in the Biotechnology industry
(Job number: 3816481)
Do you know someone who would be interested in this job?   Tell them about it.