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QC Analyst

ECLARO

Chapel Hill, NC

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JOB DETAILS
SALARY
$33.65–$36.06 Per Hour
SKILLS
Analysis Skills, Analytical Development, Dental Insurance, Diversity, FDA Requirements, Genetics, Manufacturing, Mentoring, Onboarding, People Management, Polymerase Chain Reaction (PCR), Procedure Development, Quality Assurance Methodology, Quality Control, Quality Control Methodology, Quality Management, Regulatory Compliance, Staff Training, Standard Operating Procedures (SOP), Statistics, Testing, Time Management, Vision Plan, Writing Skills
LOCATION
Chapel Hill, NC
POSTED
Today
QC Analyst
Job Number: 26-01066

Be at the forefront of innovation. ECLARO is looking for a QC Analyst for our client in Chapel Hill, NC.

ECLARO’s client is notable public research university. If you’re up to the challenge, then take a chance at this rewarding opportunity!

Responsibilities:
  • Sterility and Bioburden Testing:
    • Ability to execute Sterility Testing using the BacT Alert Sterility System.
    • Ability to execute Bioburden testing using the BacT Alert System.
    • Develop and execute analytical validations sterility and bioburden.
    • Assist in the development of analytical procedures to support sterility and bioburden testing.
  • Release and Stability Testing:
    • Familiar with Flow Cytometry, PCR, and Endotoxin testing.
    • Execute testing procedures for patient products manufactured, report results using GDP in a timely fashion and maintain in the batch record.
    • Execute testing on stability programs. Generate results and document findings.
    • Provide guidance to other employees on QC testing and techniques.
    • Responsible for training and mentoring new employees on QC process and analytical methods.
  • Analytical Development:
    • Review current validations for appropriateness to current standards and requirements.
    • Execute analytical validations as needed i.e. change in analysis to meet FDA requirements, establishment of a new site protocol requiring new testing.
    • Assist in review of analytical data.
    • Perform statistical analysis of results.
  • Manage the Quality Control requirements for the onboarding of new products.
    • Work with manufacturing lead to help bring new products to the facility.
    • Coordinate all Quality Control needs, method development, validation, SOP generation, material acquisition.
  • Investigation of existing technology to determine feasibility for new products when needed.
  • Develop the sites understanding on testing methods.
  • Author, review and revise forms, job aids, policies and Standard Operating Procedures.
  • Participate in 5 hours of continuing education annually – in cellular therapy or quality topics.
  • Responsibilities may be modified or added as needed and discussed with the appropriate management feedback.

Pay Rate: $33.65 - $36.06 / Hour

If hired, you will enjoy the following ECLARO Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO

If interested, you may contact:
Carlo Flores
Carlo.Flores@eclaro.com
646-695-2934
Carlo Flores | LinkedIn

Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.

About the Company

E

ECLARO

Eclaro is a Business and Technology Consulting Firm that connects top talent with opportunities nationwide. We have direct access to Hiring Managers from leading Fortune 1000 organizations in almost every industry segment, with particular expertise in:

• Technology and Business Consulting
• Financial Services and Insurance
• Pharmaceuticals and Life Sciences
• Consumer Products, Public Sector, and Utilities

Eclaro provides fully customizable, comprehensive talent acquisition and management of seasoned professionals through a number of business models, including:

• Consulting
• Professional Hiring
• Global Integrated Delivery™
• Managed Services

Eclaro recruits and manages a staff of highly skilled individuals in an array of specialized disciplines enabling our clients to leverage new opportunities, respond to increased and changing demands, and increase their profitability.

Eclaro’s Management Team averages over 25 years of experience in partnering with clients in technical, corporate operations and human capital solutions. We hold ISO 9001:2008 certification and have achieved SOC 2 Type 2 certification in Security, Availability and Confidentiality. Eclaro’s decades of expertise and collaborative practice have proven that The Right People are The Answer.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1999
WEBSITE
http://www.eclaroit.com

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