The purpose of this job function is to ensure quality metrics established both at the corporate and individual levels are being met.
Guidelines are established by upper management for the purpose of providing company growth and high-quality products and services for our clients.
Duties and Responsibilities
Understand client needs and requirements to develop effective quality control processes
Ensure adherence to health and safety guidelines as well as legal obligations
Collaborate with upper management to establish quality benchmarks for which measurement of will determine success
Review staff to determine appropriate procedures are being carried forward
Oversee all procedures to identify deviations from quality standards
Inspect final output and compare properties to requirements
Keep accurate documentation and perform statistical analysis
Solicit feedback from clients to assess whether their requirements are met
Submit detailed reports to supervisor
Retrieve information from ERP database, NetSuite, for the purpose of analysis and adherence to company and individual metrics established
Be on the lookout for opportunities for improvement and develop new efficient procedures
Additional Duties and Responsibilities
Meet with Upper Management at least quarterly to identify conformance and non-conformances applicable to the organization.
Requirements:
Qualifications
Proven experience as quality manager
Conscientious and responsible
A keen eye for detail and a results driven approach
Outstanding communication skills
Excellent organizational and leadership skills
Proficient in MS Office
In depth understanding of quality control procedures and relevant legal standards
Excellent math abilities and working knowledge of data analysis/statistical methods
BS/ BA in Biological Sciences, Business Administration, or relevant field
At least two years job experience working in quality assurance, preferably within a pharmaceutical or biotechnology company
Certification of training to ISO 9001:2015 Quality Management System
Certification of training to GxP guidelines
Experience with biorepository certification programs such as the College of American Pathologists accreditation or ISO 20397 certification is a plus, but not required.
Working Conditions
Work will require regular interaction with all ABS employees. Employee will also be required to work within the laboratory to observe procedures.
Physical Requirements
Work is done both at the computer for long periods of time as well as on your feet for long periods of time, depending on the activity being performed.