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Sr. QC Analyst Bioassay
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What they do
A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.
$69,465 / year median in New York
-13% projected decline
Job Description
Job Description:
Innova Solutions has a client that is immediately hiring for Sr. QC Analyst Bioassay.Position type:
Fulltime -Contract Duration:
6Months Location:
New YorkNY 10017
As Sr. QC Analyst Bioassay, you will:Job Description:
Performing routine QC testing including, but not limited to, quantitative PCR and cell-based assays in a GMP environment to support product release and stability.- Review and approval of cGMP analytical data for release and stability testing from bioassay test methods including, but not limited to, mRNA expression, functional potency and ELISA testing platforms.
- Supports and leads QC Bioassay laboratory operations (ex. Instrument qualification and maintenance. Passage cells, qualify critical reagents, etc).
- Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed.
- Support method transfer and validation activities for development, technical transfer, and validation of late-stage assays for AAV-based gene therapy programs.
- Author analytical method performance trend reports, as needed.
- Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs).
- Model leadership behaviors and mentor/train junior staff
- Work with cross functional teams with both internal and external stakeholders
Qualifications:
- BS in Cell Biology, Molecular Biology, Biochemistry or a related discipline with minimum 5+ years industry experience
- Experience in a GMP/GLP environment is a must.
- Experience in routine mammalian cell culture required
- Experience with quantitative PCR required. Experience with cell-based potency assays is required. Experience performing immunoassays such as ELISAs strongly desired
- Experience with statistical analysis (SoftMax, JMP) preferred
- Ability and desire to work in a fast-paced environment
- Independently motivated and detail-oriented with good problem-solving ability
- Strong communication, interpersonal and organizational skills.
APPLY NOW
for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. Thank you!Lailun Sheikh Phone:
412-763-1477 [email protected]PAY RANGE AND BENEFITS
Pay Range- :$55.00-$62.00 per hour.
- Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.