Sr. Quality Assurance Specialist

Revance • Newark, CA

1d • Onsite

About The Position

The Sr. Specialist, Quality Assurance is an advanced-level position with hands-on QA experience. Under minimal supervision, the individual will be working in the Product Quality Assurance team, primarily providing quality oversight and support to internal and external drug substance and drug product production and lot disposition. This individual will also provide quality support to Quality Control and Facilities. This role will be interacting with cross-functional groups such as Quality Control, Manufacturing, MSAT, Facilities, Supply Chain, and Regulatory Affairs.

Requirements

• Excellent interpersonal, verbal, and written communication skills
• Uses experience, knowledge, and judgement to resolve simple to complex issues
• Works independently with minimum supervision to accomplish goals and timelines
• Ability to organize and manage multiple tasks in a fast-paced environment, with no instruction on routine work and general instructions on new assignments
• Good working knowledge of cGMP standards applicable to commercial biologics
• Specific vision abilities required by this job include passing a visual acuity test
• Prior experience with regulatory inspections and Veeva is desired
• Bachelor’s degree in relevant field
• 6+ years experience
• Good working knowledge of cGMP standards applicable to commercial biologics
• Specific vision abilities required by this job include passing a visual acuity test
• Prior experience with regulatory inspections and Veeva is desired

Nice To Haves

• Prior experience with regulatory inspections and Veeva is desired
• Experience with aseptic fill/finish

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.
• Review documents such as standard operating procedures, master batch records, packaging and labeling records, test methods, qualification protocols, and reports
• Review executed production batch records and associated documentation, including any deviation and investigation reports related to batch disposition, for internal manufacturing and external CMO
• Review and approve quality records in a timely manner
• Act as a compliance resource to provide guidance and assistance towards resolution of deviations, lab investigations, excursions, quality investigations, OOTs, work orders, change controls, and CAPAs
• Perform area approvals and product inspection
• Support review and disposition of incoming raw materials
• Support management of the reserve sample program
• Continuously improve quality operation processes; author new and review/revise existing procedures and forms
• Assist in data verification for regulatory submissions
• Assist with inspection preparation/strategy in internal compliance audits, regulatory agency inspections, or third-party audits
• Update department databases to ensure accurate reporting of quarterly metrics

Benefits

• Competitive Compensation including base salary and annual performance bonus.
• Generous Paid Time Off, 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