Posted in Software 11 days ago.
This job brought to you by eQuest
Location: Columbia, South Carolina
Position Title: Quality Control Manager
Working Location: South Carolina
Employment Status: Full time
Required Experience: 5 years
Required Education: Bachelors
Travel Required: 0%
The Aiken, South Carolina GMS facility is currently looking for a Quality Control Manager. The responsibilities of the QC Manager include providing Quality approval of QCS’s, analytical test methods; and review for compliance with site and regulatory requirements by managing, motivating, developing, and maintaining a diverse professional staff of approximately 20 scientists and technical support staff with diverse responsibilities for finished products, raw materials, stability sample testing, analytical method and automation development and facilities monitoring. Coach these and other departmental staff while promoting team collaboration.
1. Supervision of all analytical activities in Quality area; includes OOS investigations, problem-solving, method transfers, method validations. New technology development; includes identification of appropriate technologies, research of applications, recommendation, justification, and implementation.
2. Supervision of Quality LIMS system; includes backup services for LIMS administrator, maintenance of QCS’s, test methods, and calculations.
3. Site coordinator for consumer complaint investigations and supervision of site stability program and coordinator.
4. Manage Quality capital budget; includes submitting capital proposals, obtaining approvals, ordering equipment. In addition, budget responsibilities; includes coordinating of supplies ordering to meet changing needs; approval of orders placed, assistance in management of Q overhead budget; interfacing and negotiating with contract labs for services.
5. Mange Quality equipment qualification; includes writing IQ/OQ/PQ protocols, scheduling execution, maintaining records.
6. Manage Quality equipment maintenance program; includes maintenance of vendor service contracts and scheduling of services.
7. Coordination & scheduling of Quality activities around new product launches formulation/process changes.
8. Mentor to Quality area team captains; includes guidance in decision-making, problem solving, scheduling, and staffing.
9. Document control of analytical test methods and validation reports; includes maintaining files and distribution.
10. Site analytical expert; includes participation on cross-site and sector teams (Analytical Functional Group, CAP review group, Consumer Complaints Functional Group, Compendia Review Functional Group). Compendial review coordinator; coordinate site review of compendial revisions and implementation of required changes to meet on-going regulatory standards.
The Quality Control Manager has 3-5 direct reports with 20-30 indirect reports.
• Bachelor’s degree in Chemistry, Microbiology or Related Degree
• Minimum of 5 Years Management experience in cGMP environment
• Experience conducting internal and external regulatory audits
• Experience working with FDA and International Regulatory Agencies
• Experience conducting and leading Root Cause Analysis, CAPA , and Validations
• Experience leading analytical, raw material, microbiology labs
• Understanding of technical writing procedures, investigations and technical reports
We are an Equal Opportunity Employer and do not discriminate against
any employee or applicant for employment because of race, color, sex,
age, national origin, religion, sexual orientation, gender identity,
status as a veteran, and basis of disability or any other federal,
state or local protected class.