Job Title: Quality Assurance Specialist

Job Description

In your role, you have the all-important task of preparation and review of required procedures, documentation, and retention practices, supporting inspections, and supporting ongoing continuous improvement and compliance efforts. You will be relied on to support globally across PharmSci, partner lines, and Global Supply to align goals and support the implementation of effective quality system solutions. Your skills will help you collaborate and implement practices and gain efficiencies throughout quality procedures and R&D documentation. Your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing important deliverables on time. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams. It is your dedication and hard work that will make it possible for customers and patients to receive the medicines they need, when they need them.

Responsibilities

• Perform procedural administration activities within the Global Documentation Management System.

• Partner with PharmSci business lines in the development, implementation, and management of their procedures, documentation, and records.

• Support the management of Active libraries and other documentation systems (e.g., Document Long Term Storage) for PharmSci to ensure adequate control of physical and electronic records, including logbook issuance and reconciliation.

• Manage the inventory of records within the Central Index of Company Records (CICR) system to support the creation, management, retention, and disposal of company records and information.

• Partner with the Enterprise Records and Information Management (eRIM) team to ensure alignment with record retention policies and legal holds.

• Partner with the off-site Record Service Centers to manage the lifecycle of company records and to ensure a robust process for retrieval of records in support of audits and inspections.

• Provide document technical writing, editing, and design support to other team members and supported site departments.

• Work closely with project teams to ensure that documents are accurate, internally consistent, and meet their intended purpose. Prepare documents in accordance with internal standards and external regulatory guidelines.

• Support equipment change controls, management of calibration/PM schedules, and coordination of associated documentation.

Additional Skills & Qualifications

Must-Have Requirements:

• 1+ years of experience.

• Understanding of cGMP, Data Integrity, and ALCOA principles.

• Strong organizational and communication skills.

• Strongly skilled in word processing and document formatting; very experienced in Microsoft Office applications (Word, Excel, PowerPoint, Visio).

Nice-to-Have Requirements:

• Relevant pharmaceutical experience.

• Demonstrated technical writing experience is desirable.

• Strong project management skills.

Work Environment

You will work in a collaborative environment that supports the development, implementation, and management of quality systems and documentation. The role requires proficiency in using various documentation systems and Microsoft Office applications. Expect to engage with cross-functional teams to ensure document accuracy and compliance with regulatory guidelines. The work environment is dynamic, requiring you to manage multiple tasks and projects simultaneously while maintaining high standards of quality and compliance.

Pay and Benefits

The pay range for this position is $25.00 - $26.00

• 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 fully onsite position in Bothell,WA.

Application Deadline

This position will be accepting applications until Dec 6, 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.