QC Technician II 1st Shift

Work Schedule

Flex 10 hr shift/days

Environmental Conditions

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

Job Description

Compensation: $18.65 - 25.00/HR

Work Schedule

Shift: 1st Shift Monday-Thursday

Shift Hours:7:00AM 5:30PM

QC Raw Materials Technician II

As part of the Thermo Fisher Scientific team youll 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 worlds 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) thatis seekingsharp individuals to bring the highest quality processesproductsand testing to our clients. Our employees are committed to making a difference in our organization for our client partners and the patients we serve.

Pharma Services Viral Vectors 5 Commerce Drive Plainville MA

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

What We Offer:

This position may be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. 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: and Benefits

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. 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: Experience:

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