Who We Are:
Headquartered in Indianapolis, Indiana, United States, Harlan Laboratories is a privately held global provider of essential pre-clinical research tools and services that enable innovative and efficient discovery and development research. We work with the pharmaceutical, biotechnology, medical device, agrochemical, chemical and food industries, as well as universities, government, and other research organizations. We have expanded through both acquisitions and organic growth, and we are known to our customers for our consistent product quality and customer service. Our focus is on providing customers with products and services to optimize the discovery and safety of new medicines and compounds.
Is Harlan Right For You?
Are you enthusiastic and high energy? Do you have a zest for making a difference? Are you passionate about delivering meaningful results and contributing to the success of an organization? Then consider a career at Harlan and together, we can achieve extraordinary outcomes.
- Manage the Quality Assurance department and over all expectations pertaining to setting accurate schedules, costs and resources
- Manage the quality system design including improvement, non conformance management, CAPA investigations and deviation monitoring.
- Oversee the development and implementation of an FDA complaint Quality System for GMP activities
- Ensure delivery against QA department goals and objectives, i.e. meeting commitments and coordinating overall quality assurance schedule.
- Provide necessary definition, development and deployment of the production quality assurance strategy, addressing all phases of production
- Directly manage quality assurance assistants and metrology staff including preparation and delivery of staff development activities and performance reviews.
- Direct the organizations proactive quality assurance procedures designed to prevent defects and improve performance
- Consult with company’s other departments including sales in order to meet the high expectations of GMP clientele
- Implement ongoing quality improvement processes working with interdepartmental teams
- Manage the qualification and validation of all critical GMP equipment including writing validation protocols to meet all GMP requirements
- Anticipate product release problems and take corrective or preventive action, escalating as needed, to resolve and achieve commitments.
- Assure the viability, functionality and effectiveness of essential tools.
- Coordinate and lead all on-site quality audits of the facility
- Manage all vendors hired to perform calibrations of equipment within the facility.
- Manage customer complaint files including root cause analysis and corrective action
- Approve all productions prior to shipment
- Design and lead all cGMP training throughout the facility
- Provide leadership in achieving and maintaining compliance with regulatory requirements
- High school education or equivalent with at least 5 years progressive responsibility in a similar position or an undergraduate degree with three years prior experience in a similar position
- Should be very familiar with regulatory requirements including GMP, GLP and USDA
- Must have strong investigational skills
- Must be able to type accurately with excellent grammar and proofreading skills and display proficiency in technical writing
- Must be familiar with calibration software such as ProCal
- Proficient in MS Office Suite (Word, Excel, Power Point etc.)
- Must display the ability to work independently, prioritize workload and be a self-starter
- Must display strong leadership and team work skills
- Must be able to multi-task on a daily basis
- Must display excellent English verbal and written communication skills
- Must be able to handle confidential/sensitive material
- Must be able to work with clients throughout all levels of the organization.
- Must display a strong interest in Quality Assurance
Harlan is an Equal Opportunity Employer
Harlan Laboratories - 2 years ago