Quality Assurance Manager

The basic function of the Quality Assurance Manager (QAM) at Episciences, Inc. is to ensure that Episciences, Inc. products (drug and cosmetic) are manufactured in strict adherence to the established formulations, current Good Manufacturing Practices (cGMP), and Episciences, Inc. quality standards.

The QAM is responsible for coordinating all parts of the Quality control Unit (QCU) including: primary and alternate QCU personnel, sampling and testing of all products and product components throughout all stages of manufacturing, deviation and complaint investigations, internal compliance audits, and ensuring compliance with 21 CFR 211 regulations.

It is the responsibility of the QAM to ensure that products and components have been approved or rejected pursuant to Episciences, Inc. quality standards.

The QAM is obligated to review and approve production batch records, standard operating procedures, testing protocol changes, and validations.

The QAM must maintain cross-departmental relationships; many of the QCU processes and responsibilities overlap multiple departments.

• Read, interpret, comply with, and ensure full company compliance with 21 CFR 211.
• Ensure the timely review and approval of production batch records, standard operating procedures, out-of-specifications investigations, complaints, and procedure deviations.
• Initiate and conduct internal audits.
• Direct cGMP training and review for manufacturing personnel.
• Record and file data electronically, physically and in adherence to 21 CFR 211.
• Comply with all directives issued by the Vice President of Manufacturing.

What we expect of you:

• Minimum of a Bachelor of Sciences Degree with emphasis in Chemistry or Biology and including college level laboratory experience and proficiency with microscopy, pH and viscosity measurements, microbiological sampling and plating, and clean room lab operations.
• At least one year of production chemistry experience; preferred two or more years of drug or cosmetic quality assurance/control experience.
• Inter-office communication skills and general administrative duties with experience in maintaining proper and accurate inventory and control records, files, and data entry. Experience with Microsoft Office is helpful.
• The sense of sight (corrected to normal range), English language competency, full range of body motion (including lifting up to 40 pounds), manual and finger dexterity, hand-eye coordination.
• The physical requirements include sitting, standing, walking and light lifting.
• Shift hours will generally be from 7:30am to 4:00pm Monday thru Friday, allowing for one 15 minute break in the AM, one 15 minute break in the PM, and one 30 minute lunch break. Occasionally work may require longer hours.
• The majority of time will be spent in an office environment. Approximately 10% of time will be spent in a restricted access clean lab environment.