Quality Assurance Specialist

We are seeking a highly skilled and experienced Quality Assurance Expert to evaluate and approve production department-generated documentation, including electronic and paper batch records. The ideal candidate will support the on-time release of API active pharmaceutical ingredients and drug substance products, provide technical guidance to production operators and management, and ensure compliance with cGMP requirements.

Key Responsibilities:

Evaluate and approve electronic and paper batch records.Review API active pharmaceutical ingredients and drug substance products.Provide technical guidance to production operators and management.Identify and assess deviations in batch records using scientific principles and compliance-minded thought processes.Ensure compliance with cGMP requirements within established timelines.

Qualifications:

Bachelor's degree in a scientific/technical field.Minimum 7 years of experience in the biopharmaceutical, biologics, medical device, or related industry.Knowledge and understanding of cGMP concepts and applicable US and foreign regulations.Minimum 4 years of direct experience in Manufacturing and/or Quality in a GMP-regulated industry or an equivalent combination of education and experience.Previous experience reviewing and approving pharmaceutical manufacturing electronic and paper batch records.Proven ability as a team player and leader.Excellent interpersonal skills.Ability to listen and understand the opinions and perspectives of others while influencing without authority.Ability to work both independently and in a team environment.Strong written and oral communication skills.Ability to assess, investigate, and resolve deviations.Strong ability to plan and prioritize complex and conflicting objectives to meet release goals.In-depth knowledge of GMP.

Skills:

Continuous ImprovementProcess ImprovementDetail OrientedMonitoringDefect PreventionCommunication

Pay and Benefits

The pay range for this position is $37.00 - $48.00/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 Berkeley,CA.

Application Deadline

This position is anticipated to close on Feb 6, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.