Operations, Clinical Quality Assurance Specialist

3 weeks ago

Allentown, United States Thermo Fisher Scientific Full time

When you are part of the team at Thermo Fisher Scientific, you’ll 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.

**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.

**What will you do?**

**How will you get here?**
- Bachelor’s degree

**Responsibilities**
- Applies Good Manufacturing Practices (cGMP) in all areas of responsibility.
- Demonstrates and promotes the company vision.
- Establishes procedures for maintaining quality standards.
- Promotes and implements company quality requirements.
- Evaluates and develops techniques to maintain awareness of SOP’s, cGXP’s and clinical and/or commercial requirements.
- Leads and 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.
- Works with Operations Managers to implement RFT portfolio.
- Author’s, revises, and follows all relevant SOP’s and Work Instructions.
- Resolves and assures that issues potentially affecting product quality/compliance are raised to the attention of the Management.
- Assures that issues are resolved in a timely manner and corrective actions are implemented accordingly.
- Quality Sponsor / Client Facing - Interacts with clients on quality issues, acting as an advocate on the company’s quality concepts.
- Conducts all activities in a safe and efficient manner.
- Other duties may be assigned to meet business needs.

**Knowledge, Skills, Abilities**
- Bachelor’s degree, preferably with a technical or life sciences focus.
- A minimum of 5 years of experience in Pharmaceutical or related, regulated industry.
- Experience with Quality Systems (e.g., Change Control, deviations, complaint management, and documentation management).
- Experience mentoring junior staff.
- 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.
- Weekend support required.
- Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP
- Must be skilled in decision-making, establishing 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.

At Thermo Fisher Scientific, each one of our 67,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
- 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. _

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