Quality Assurance Specialist III

Revance • Newark, CA

3h • Onsite

About The Position

The Quality Assurance Specialist III is an advanced level position with hands-on QA experience. Working independently and under minimum supervision, the individual will be working primarily in quality operations providing quality assurance support to CMC teams and to in-house DS and DP production, QC testing and systems. The individual will be interacting with cross-functional groups such as Materials Management, Validation, Quality Control, and Manufacturing departments.

Requirements

• Bachelor’s degree & 4-6 years of directly related experience
• Minimum 4-6 years' experience in the pharmaceutical or biotechnology industry with at least 4 years working in direct manufacturing, Quality Control, or Quality Assurance; experience in aseptic manufacturing processes is highly desirable.
• Ability to work with all levels cross-functionally.
• Good working knowledge and understanding of 21 CFR Parts 210, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents.
• Excellent interpersonal and verbal and written communication skills
• Good working knowledge of quality systems cGMP standards applicable to commercial biologics DS and DP.
• Works independently with minimum supervision to accomplish goals.
• Relies on extensive experience and judgment to resolve simple to moderately complex issues.
• Ability to organize and manage multiple tasks in a fast-paced environment, with no instruction on routine work and general instructions on new assignments.
• Specific vision abilities required by this job include passing a vision test in order to perform statistical inspections of drug products.
• While performing the duties of this job, the employee is regularly required to stand or sit; converse and listen to individuals; use arms and legs to transfer materials from one location to another; and use hands and fingers to operate a computer and telephone keyboard.
• This job will require the employee to be able to multi-task different activities and be able to perform duties with attention to detail.

Nice To Haves

• 6 years of experience in the pharmaceutical or biotechnology industry with at least 4 years working quality operations involving aseptic fill, finish, and packaging operations is preferred.
• Prior experience with regulatory inspections is desired.

Responsibilities

• Perform a wide variety of quality assurance activities to ensure compliance with Revance procedures, applicable US and international regulatory requirements for biologic drug substances and drug products under clinical development and commercial manufacturing.
• Perform incoming quality attribute inspections; review and disposition of incoming raw materials (e.g. chemicals, packaging and labeling materials, components etc.).
• Review documents such as standard operating procedures, master batch records, packaging and labeling records, sampling plans, test methods, qualification protocols, and reports.
• Review executed production batch records and associated documentation including any deviation and investigation reports related to lot release.
• Review of Quality Control, Analytical Development, and Validation protocols, reports.
• Perform retain sampling and support the reserve sample program.
• Perform area approval, line clearance and product inspection.
• Perform product complaints investigations.
• Actively update department databases to ensure up-to-date reporting of metrics.
• Support continuous improvement of quality operations and department databases; author new, revise existing and may review department procedures and/or forms.
• Support quality systems, as needed (e.g., issue and track closure to change controls, deviations, quality investigations, CAPAs).
• Assist with inspection preparation and inspection strategy room for regulatory agency inspection or third-party audits.
• Act as a compliance resource to provide guidance and assistance towards resolution of simple to moderate deviations, quality investigations, lab investigations, CAPAs and change control; review and may approve quality system documents related to manufactured products.
• Assist in data verification of DS and DP sections of regulatory submissions as needed.
• Assist in the internal compliance audits as needed.

Benefits

• Competitive Compensation including base salary and annual performance bonus.
• Flexible PTO, holidays, and parental leave.
• Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees