Quality specialist ii

When you are part of the team you will do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe.

Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Fisher Clinical Services, part of Thermo Fisher Scientific, is a leading provider of global clinical supply chain. With unwavering commitment to service, science and process engineering, we are powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivaled expertise.

We are exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. Whether planning, packaging, labeling, storing, or distributing the important supplies needed to perform clinical research, for more than 27 years Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standards.

Location / Division Specific Information

CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time a concept that we internally embrace as There is a Patient Waiting.

Our unique blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more.

Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters.

Discover Impactful Work :

The Operations, Clinical Quality Assurance Specialist II will support all Quality functions in relation to packaging activities of clinical product processed through primary and secondary packaging operations.

Support of commercial packaging activities is also included. The role involves supporting management and the quality team and close interaction with relevant cross functional groups at the site.

The role requires problem solving and effectively ensuring the site follows established quality systems. Additionally, to the ability to effectively communicate both verbally and written.

Candidate should have experience with cGMP regulations.

A day in the Life :

• Applies Good Manufacturing Practices (cGMP) in all areas of responsibility.
• Demonstrates and promotes the company vision.
• Establishes procedures for maintaining quality standards.
• Promotes and enforces company quality requirements.
• Performs QA Inspector functions, as needed (In-process checks, job start up, verification of floor activities).
• Leads and successfully completes QA training sessions for CGP’s, SOP’s, company requirements, etc.
• Extensively interacts with Operations Managers to resolve quality issues.
• Works with Area Manager QA to review significant aspects of operations related to quality.
• PPI - Problem Solving / Execution for QA Operations.
• GTW Change controls, actions items, effectiveness checks.
• Performs root cause investigations for nonconforming issues. Aligns with Operations Investigators on deviations RAPID.
• Authors, revises, and aligns with all relevant SOP’s and Work Instructions and accurately documents activities.
• Resolves and assures that issues potentially affecting product quality / compliance are escalated to the attention of the Management.
• Assures that issues are resolved in a timely manner and corrective actions are implemented accordingly.
• Interacts with clients on quality issues, as necessary.
• Conducts all activities in a safe and efficient manner.
• Other duties may be assigned to meet business needs.

Keys to Success : Education :

Education :

Associate's degree required, preferably with a technical or life sciences focus.

Experience

• 3 years of experience in Pharmaceutical or related, regulated industry.
• Experience with Quality Systems (, Change Control, deviations, complaint management, and documentation management).
• Experience mentoring junior staff and good leadership skills.
• Excellent verbal and written communication and be able to communicate effectively with customers.
• Must have good working knowledge of cGMP Regulations
• Must be able to work independently.
• Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP
• Must be skilled in decision-making, building relationships, problem solving, planning and organizing.

Physical Requirements

• Extensive standing and walking on packaging floor in order to monitor room activities.
• Work schedule, Monday through Friday, 8 hours per day. Additional overtime and weekend (Saturday or Sunday) work may be required.
• This position requires standing, bending and lifting. Exerting and lifting up to 25lbs of materials occasionally, and 10lbs of materials regularly.
• The position is exposed to cold temperatures for more than one hour at a time.
• The position is exposed to -20F temperatures for at least 15 minutes at a time.
• The position will be exposed to atmospheric conditions could require special personal protection equipment.
• Position is responsible for inspection of pharmaceutical products, components and labels. Incumbent must meet applicable visual acuity / color blindness standards to perform visual inspections in a cGMP environment.

BENEFITS :

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.

We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain .

As one 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.

StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Last updated : 2024-09-06