Operations, Clinical Quality Assurance Specialist III

at  Thermo Fisher Scientific

JOB DESCRIPTION

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.
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, Fisher Clinical Services is 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. http://www.fisherclinicalservices.com

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.
  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.
  This job description is intended to describe the general nature and level of work assigned to individual filling this position. This is not intended to be an exhaustive list of all responsibilities, duties or skills required. This job description is subject to change as the needs and requirements of the department and business change

WHAT WILL YOU DO?

The Operations, Clinical Quality Assurance Specialist III 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 the ability to problem solve and effectively ensure the site follows established quality systems. Additionally, the role requires strong communication skills both verbally and written. Candidate should have experience with cGMP regulations

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.