Description
Job Opportunity:A Molecular Diagnostics Company is in need of a knowledgeable and experienced Quality Control Lead to play a key role in establishment and hands-on operation of a QSR (21 CFR 820) and ISO 13485:2003-compliant Quality Control function. The candidate should be hands-on and comfortable working in a fast-paced company. The candidate will work with upper management to develop and implement the required procedures to perform Quality Control testing of in vitro diagnostic tests and medical devices. Excellent writing, verbal communication and organizational skills are critical.
Role and Responsibilities:
- Work with Quality Assurance and Product Development to develop written procedures for quality control testing of raw materials, work-in-process and finished goods.
- Develop practical methods to perform cGMP-compliant QC testing within a laboratory also performing Product Development and CLIA-compliant reference laboratory procedures.
- Perform cGMP-compliant Receipt, Inspection and QC test procedures, including completion of all required documents and records.
- Develop and implement Quality Metrics for the QC function.
- Participate in test method validation projects.
- Participate in diagnostic product verification and validation studies.
Education, Certification/Licensing and Experience:
Required:
- Bachelor Degree in chemistry, biochemistry or life sciences.
- Five or more years of relevant QC experience in a cGMP-compliant environment under FDA regulation.
- At least 2 years of experience at the QC Specialist, Lead or Supervisor level.
Highly desired:
- Experience with QC of in vitro diagnostic test products.
- Experience with molecular biology laboratory methods.
- Training in statistical methods.
Language Skills: Must be proficient in written and verbal communication in the English language.