Quality Associate, Operations Bothell, WA

ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.

Use Your Power for Purpose
Every day our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible innovative and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development maintenance compliance or research analysis your contributions have a direct impact on patient care. By being part of our team you help uphold a quality culture that adapts and evolves to meet the needs of patients ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes.

What You Will Achieve
In this role you will:

Perform on-the-floor QA tasks within the manufacturing areas as needed collaborating with manufacturing and other departments to provide routine quality support and maintain inspection readiness.

Conduct on-the-floor QA review of executed batch records and other manufacturing documentation to ensure adherence to site procedures regulatory standards and filing requirements.

Provide triage support across departments to address quality issues ensuring timely escalation to management when necessary.

Review and approve deviations including the associated investigation reports and corrective/preventative actions.

Author review and approve SOPs as appropriate for both Operations and Quality.

Assist with additional tasks including (but not limited to) Master Data management / approval GMP area walkthroughs product changeover activities.

Participate in internal audits support regulatory inspections or corporate audit activities as needed.

Additional Qualifications/Responsibilities
Here Is What You Need (Minimum Requirements)

Applicant must have a bachelors degree with 0 years of experience; OR an associates degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience

Experience in the pharmaceutical industry and Quality administered systems

Sound knowledge of current Good Manufacturing Practices (part of GxP)

Ability to work effectively in a team environment both within ones own team and interdepartmental teams

Effective written and oral communication skills

Bonus Points If You Have (Preferred Requirements)

Experience at a manufacturing site.

Managing and writing deviations

Experience in production batch record review Enterprise Resource Planning system investigation of non-conformance root cause analysis and change control management

Strong problem-solving skills

Ability to work independently and as part of a team

Excellent time management and multitasking abilities

Effectively manages stressful situations able to focus on task at regardless of circumstances and stress induced pressure


PHYSICAL/MENTAL REQUIREMENTS

Good judgment and correct decision making based on company procedures/standards technical experience and industry guidance / regulatory requirements.

Collaboration skills and the ability to independently engage with a wide range of colleagues and management to gather the input and background knowledge needed to complete assignments.

Must be able to gown for entering controlled areas.

Must be able to wear specialized protective clothing wear PPE (safety shoes/glasses/etc.).

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

This role is primarily a Wednesday - Saturday schedule (4/10s) with 24/7 support of manufacturing as quality issues arise (10 am - 8 pm)

Work Location Assignment: On Premise
The annual base salary for this position ranges from $66500.00 to $110900.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution paid vacation holiday and personal days paid caregiver/parental and medical leave and health benefits to include medical prescription drug dental and vision coverage. Learn more at Pfizer Candidate Site U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.