Director of Compliance and Quality Assurance

Exciting leadership opportunity with a growing skin care manufacturing company.

Reporting to the Vice President of Manufacturing, the Director of Quality & Compliance is responsible for ensuring that Episciences, Inc. products (drug and cosmetic) are manufactured in strict adherence to the established formulations, current Good Manufacturing Practices (cGMP), and quality standards. The Director of Quality & Compliance coordinates all parts of the Quality Control Unit (QCU). Including but not limited to: 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 FDA 21 CFR 211 regulations.

The ideal candidate will have:

• Working knowledge/experience of FDA cosmetic and OTC drug regulations; EU, UK, and Canada cosmetic regulations; and cGMP.

Responsibilities:

• 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.
• Full direction/coordination of the Quality and Batching Departments.
• Comply with all directives issued by the Vice President of Manufacturing.
• Keep executive management advised on and in compliance with all pertinent international regulations.
• Maintain cross-departmental relationships.

Minimum Qualifications:

• 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 preferred.
• 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.

Education and Experience:

• Minimum: Bachelor of Sciences Degree with emphasis in Chemistry or Biology
• 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.

Salary Information:

• Starting salary range: $68,000 - $75,000 DOE

Location: Based in Boise, Idaho

Excellent benefits package includes:

• Medical, dental, vision, and life insurance
• PTO and 11 paid holidays
• Generous company perks

Employment Type:

• Full-time, Exempt

Job Type: Full-time

Pay: $68,000.00 - $75,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Day shift
• Monday to Friday
• No nights

Ability to Commute:

• Boise, ID 83704 (Required)

Ability to Relocate:

• Boise, ID 83704: Relocate before starting work (Required)

Work Location: In person

Salary : $68,000 - $75,000