This is a non-supervisory role, reporting to QA supervisor - Cell Therapy, which is a sub-group within the Quality Unit.

A Quality Specialist I is a QA professional who performs QA on-the-floor activities, material release, new product introductions, driven batch record review, performed Quality Control data review, and review and approval of deviations, CAPAs, Out of Specifications or Out of Trends, Standard Operating Procedures (SOPs). All activities are in support of producing and releasing Cell Therapy product for clinical clients. In addition, Quality Specialist I may be required to support other Quality Management Systems of the Cell Therapy organization on an as needed basis. This support could include, but is not limited to, implementation of new electronic systems, supplier quality management, internal and external audits, and continuous process improvement.

Location/Division Specific Information

Patheon, Cell Therapy Division, San Franciso, California

How will you make an impact?

Provides leadership by performing the following: developing and empowering colleagues; encouraging relationships; putting self and colleagues in a position to succeed, meeting personal career goals while also achieving organizational goals; doing your part to be a member of effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and contributing to a climate where colleagues are motivated to do their best.

What will you do?

The jobholder will support the Network Quality and Site Leadership teams in delivering the following work:

Responsible for completing training tasks based upon a monitored curriculum

Spend up to 50% of work hours in manufacturing areas when production is on-going to oversee activities from a quality perspective and answer QA-relevant questions / provide QA input in real-time.

Responsible for performing QA approval of suite and equipment changeover between manufacturing processes.

Serve as QA approver for minor/major deviations (when delegated), batch record revisions, SOP revisions, and other required site documentation.

Individuals in this group must be able to obtain buy-in and cooperation to resolve issues and maintain quality culture and quality standards throughout Operations with no direct authority over the people with whom they interact. Utilization of tact and diplomacy with internal and external customers is essential.

Participate in audit support for regulatory and/or client inspections.

Ensures all activities are in compliance with FDA, EMA and other cGMP regulations, including any customer requirements and international regulatory requirements.

Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision-making and ambition.

Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers.

Highly functioning team member in a multi-skilled, dynamic business environment.

Experience with Enterprise Software (i.e. TrackWise, eDMS, LIMS, etc.)

Strong verbal and written communication skills

Strong proficiency in Microsoft Office Suite (Word, Excel, Project, and PowerPoint).

Ability to function in a rapidly changing environment and balance multiple priorities simultaneously

Cultivate relationships and drive team engagement to build a climate where colleagues are motivated to do their best

Performs any other tasks as requested by Senior Management to support Quality activities and/or the needs of the business.

How will you get here?

Education

BS/ BA in biology, biochemistry, chemistry or other science related field

Experience

3+ years within a GMP Environment

2+ years of experience within a Quality Role, preferred

Proficient with computers (MS Office). Solid understanding of controlled documentation and data systems.

In depth knowledge of cGMP regulations.

Knowledge, Skills, Abilities

Knowledgeable of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.

Ability to apply GMP regulations and other international guidelines to all aspects of the position.

Demonstrated ability to make key decisions.

Technical writing skills.

Can communicate in English (written and verbal)

Must be able to interact and communicate optimally with other departments to meet project milestones and goals.

Excellent interpersonal, analytical/problem solving and communication skills.

Ability to aseptically gown and/or sterile gown as needed

Ability to work within environmental clean rooms

Proven dedication to our fundamental principles of Integrity, Respect and Excellence

Ability to function in a rapidly changing environment and balance multiple priorities simultaneously

At Thermo Fisher Scientific, each one of our 120,000 outstanding minds has a unique story to tell. Join us and contribute to our unusual mission—enabling our customers to make the world healthier, cleaner and safer.

Compensation:

The estimated pay range is $26 - $35+ / hr. Actual compensation will be confirmed in writing at time of offer.

• Review our company’s Total Rewards
• Medical, Dental, & Vision benefits-effective Day 1
• Paid Time Off & Holidays
• 401K Company Mat
• Tuition Reimbursement - eligible after 90 days
• Employee Referral Bonus
• Employee Discount Program
• Recognition Program
• Charitable Gift Matching
• Company Paid Parental Leave
• Career Advancement Opportunities

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As a team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.