Easter Seals Jobs

Job Title: Quality Assurance SpecialistMUST HAVE

• 3-5 years of relevant experience in a GMP environment for pharma/biotech manufacturing

• BS or BA degree

• Experience with change control

• Quality assurance

• Document control

• Change control in a GxP environment - minimum of three years

• Technical writing

• Pharma/biotech industry experience - minimum of three years

• Project management - ability to manage timelines and prioritize tasks

Job Description

The Quality Assurance Specialist is responsible for managing change controls related to manufacturing products, processes, equipment, facilities, and computerized systems. This role contributes to the oversight of key strategic, tactical, and operational goals. The specialist will independently review, initiate, complete, and thoroughly document critical, major, and minor change controls, managing both local and global change controls and associated activities related to GxP operations.

Responsibilities

• Manage change controls related to manufacturing products, processes, equipment, facilities, and computerized systems.

• Review, initiate, complete, and document critical, major, and minor change controls.

• Facilitate cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance with QMS expectations.

• Navigate through complex change review discussions, facilitating decisions regarding approach and follow-up actions, and documenting the decisions and evaluations.

• Support management and monitoring of change records for adherence to organizational or departmental metric targets and maintenance of associated tracking tools/databases.

• Support the management review process through development and generation of quality system metrics and trending, escalating issues as required.

• Maintain and improve quality systems processes as needed.

• Work directly with operating entities and internal clients to ensure follow-up of change tasks.

• Participate in compliance audits as required.

• Maintain programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (cGMPs).

• Write and/or implement changes to controlled documents (e.g., SOPs, Specifications, Methods) as needed.

• Provide guidance and technical knowledge to more junior staff and monitor the performance of daily tasks.

Work Environment

The work environment is hybrid, with required onsite presence on Tuesdays, Wednesdays, and Thursdays. Mondays and Fridays are work-from-home days.

Pay and Benefits

The pay range for this position is $45.00 - $48.00

• 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 hybrid position in Foster City,CA.

Application Deadline

This position will be accepting applications until Dec 11, 2024.

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.