QA Specialist II - Deviation Management
QA Specialist II - Deviation Management
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
Work Schedule
First Shift (Days)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)
Job Description
Join Thermo Fisher Scientific to contribute to finding cures protecting the environment and ensuring food safetyall while advancing your career.
Location/Division Specific Information
This position will be based at the Thermo Fisher Scientific site located in Millersburg PA.
How will you make an impact
Be part of a fastgrowing manufacturing site that is committed to operational quality in manufacturing and across the supply chain. This position will be crucial to enabling yearoveryear doubledigit growth by assisting with sitecritical Deviation Management projects using crossfunctional teams.
What will you do
- Trackwise records management and associated results
- Review edit and approve existing procedures
- Develop new SOPs as needed to close QMS gaps and drive continuous improvement
- CAPA timeline management
- Interact/lead deviation management activities within a crossfunctional team
- Investigate and perform RCA (root cause analysis) activities; cascade knowledge and work with functional department owners/leads
How will you get here
Education:
- Minimum Requirement: HS Diploma/GED
- Preferred: Associates Degree or equivalent experience
Experience:
- 2 years of quality management system experience
- Experience working in a team environment
- Experience in efficiently crafting top quality work under daring timelines
Preferred Experience
- Strong working knowledge of FDA Quality Systems Regulations (21CFR820) and International Quality System Standards (ISO13485)
- Ability to understand various manufacturing processes and quality processes
- Excellent written and communication skills
- Ability to interact with/lead at all levels of the organization
- Develop and implement procedures
- Ability to perform investigative processes as well as critical thinking and problem solving
- Knowledge of statistical based computer programs such as Excel and/or Minitab as well as Microsoft Office
- Strong Root Cause/Problem Solving skills
Knowledge Skills Abilities
- Detail Oriented
- Knowledge of Schedule Planning Meeting Minutes Action Items & Reminder Notifications
- Positive demeanor and confirmed communication skills
- Ability to prioritize and balance multiple projects simultaneously
- Ability to influence without authority
- Ability to develop credibility and positive professional relationships with subordinates peers and upper management
- Proficient in Microsoft Office Applications
- Ability to travel (<10%)
#skilledmillersburg
Required Experience:
Unclear Seniority
Employment Type
Full-Time
