QC Technician II - 1st Shift

QC Raw Material Technician II

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Division/Site Specific Information

Thermo Fisher Scientific - Viral Vector Services (VVS) is a multifaceted gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization for our client partners and the patients we serve.

How will you make an impact?

The QC Raw Material Technician II provides critical sampling activities of the raw materials that will be used to manufacture leading edge viral vector therapies to our clients. The Plainville, Massachusetts site has become a key manufacturing facility, and this team will be instrumental in supporting the production and timely delivery of critical therapies to patients.

What will you do?

• Raw Materials Inspection: to include but not limited to;
  Review of received goods, documenting appropriate particulars (e.g. lot numbers, expiry dates, etc), cross-referencing information against documentation, detecting incorrect goods and notifying appropriate personnel
• Raw Material Sampling:
  Arrange and collection, labeling and storage of samples where required as per material Specifications, and perform sample adjustments in SAP
• Perform material transfer and gown into clean rooms
• Perform equipment cleaning
• Ability to create purchase requests and ship raw materials for testing to external/internal laboratories
• Reconcile test results for release of GMP materials
• Identify, escalate, and support investigations for any identified internal and/or external non-conformances identified during QC checks, or notified to QC by another function
• Performing documentation review of general processing documents such as, but not limited to;
  Receipt Records and Laboratory Processing Records
• Performing additional QC check duties as identified by the QC Team Manager and governing SOPs
• To ensure during review documentation is correct, GMP compliant, error-free, and entered operating systems appropriately
• Perform ad hoc duties, as requested by the QC Team Manager or Senior Manager, Quality, to support activities of the Quality department
• Review and author SOP, Forms, Material Specifications, and related documents
• Train personnel on OJTs
• Occasionally attend site meetings and act as liaison with contract testing labs

Keys to Success:

• Education:
  
  High school diploma or equivalent required.
• Experience:
  
  1 year of previous work experience in manufacturing, operations, production, lab setting, or related field. Experience working in a GMP (GxP) environment preferred. Knowledge in the use of Pharmacopeia such as USP, EP and JP preferred

Knowledge, Skills, Abilities

• Ability to handle multiple assignments and changing priorities.
• Positive, proactive approach to drive assignments/tasks to completion.
• Ability or capable of lifting twenty (20) lbs, with or without accommodation
• A high degree of accuracy and attention to detail
• Ability to read and interpret general procedures
• Ability to calculate figures and amounts such as percentages
• Proficient in personal computer skills; specifically, Microsoft Office, Outlook and database management
• Requires good written, verbal, and interpersonal communication skills and the ability to effectively interact with all levels.
• Ability to demonstrate experience of working without direct supervision/under own initiative within the remit of the role

Physical Requirements / Work Environment :

• May include working with dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, as well as marked changes in temperature

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