QC Analyst
ECLARO · Chapel Hill, NC · 2 mo ago
On-siteQuality Assurance$33.65–$36.06/hrContract
Responsibilities
- Execute Sterility Testing using the BacT Alert Sterility System.
- Execute Bioburden testing using the BacT Alert System.
- Develop and execute analytical validations for 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.
- Manage the Quality Control requirements for the onboarding of new products.
- Work with manufacturing lead to help bring new products to the facility.
- Cook up all Quality Control needs, method development, validation, SOP generation, material acquisition.
- Investigate 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.
- Bachelor's degree in a related field.
- Minimum of 2 years of experience in a similar position.
- Knowledge of sterility and bioburden testing methods.
- Experience with Flow Cytometry, PCR, and Endotoxin testing.
- Strong analytical skills and attention to detail.
- Ability to work independently and as part of a team.
- Excellent communication and problem-solving skills.
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO
Qualifications
Pay
$33.65 - $36.06 / Hour
Benefits
Contact
If interested, you may contact: Carlo Flores
Carlo.Flores@eclaro.com
646-695-2934