QC Technician II - 1st Shift

About the Role

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.

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.

Responsibilities

• 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

Requirements

• High school diploma or equivalent required
• 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

Skills

• 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

• Able to lift 40 lbs. without assistance
• Adherence to all Good Manufacturing Practices (GMP) Safety Standards
• Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed
• Cold Room/Freezers -22degreesF/-6degrees C
• Office
• Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
• Warehouse
• May include working with dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, as well as marked changes in temperature

Pay

The hourly pay range estimated for this position based in Massachusetts is $18.65–$26.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

Schedule

Flex 10 hr shift/days. Shift: 1st Shift, Monday-Thursday. Shift Hours: 7:00AM – 5:30PM.

Benefits

We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards