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Responsibilities/Essential Duties:

+ Perform a wide variety of Quality Assurance activities to ensure compliance with Revance procedures and applicable US and international regulatory requirements for biologic drug substances and drug products.

+ Contribute to the development, implementation, and maintenance of Deviation, CAPA, and Change Control programs.

+ Provide quality oversight of GxP Quality Events including deviations, CAPAs, change controls, lab investigations, and complaints.

+ In collaboration with cross-functional GxP groups, coordinate and track the timely closure of Quality Events.

+ Support Business Owner responsibilities for the use and management of Veeva electronic Quality Management System.

+ Participate in the Change Control Review Board with cross-functional GxP Leads in the review and endorsement of GxP changes.

+ Support the development, collection, and management of quality metrics and key performance indicators to optimize performance, productivity, and effective resource planning.

+ Support continuous improvement of quality systems by authoring new or revising existing department procedures and forms.

+ Assist in internal compliance audits as needed.

+ Provide inspection readiness support and assist during inspections by regulatory authorities or other third parties.

+ Other duties as assigned.

Basic Qualifications:

+ Master’s degree & 2 years of directly related experience; OR

+ Bachelor’s degree & 4 years of directly related experience; OR

+ Associates degree & 6 years of directly related experience

Preferred Qualifications:

+ Bachelor’s degree or equivalent in biology, chemistry or related science or equivalent experience.

+ Minimum 5 years of GMP experience in pharmaceutical and/or biotech related fields.

+ Working knowledge of quality systems cGMP standards applicable to biologics drug substance and drug product.

+ Works under moderate supervision.

+ Ability to independently analyze and reconcile simple issues.

+ Ability to organize and manage multiple tasks in a fast-paced environment, with minimal instruction on routine work and moderate instructions on new assignments.

+ Excellent verbal and written communication and interpersonal skills.

+ Proficient with commonly used word processing, database systems, and other software.

Pay and Benefits

The pay range for this position is $35.00 - $43.42/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Newark,CA.

Application Deadline

This position is anticipated to close on Jun 5, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.