Biotechnology company is hiring an a Quality Control Analyst II to contribute to the development and performance of Quality Control methods, systems, policies, processes, procedures, and controls as they related to the analytical testing of clinical materials.
This is a 6-month contract with a potential for extension.
Responsibilities
- Performs release, stability, and in-process testing of materials, samples, and final products.
- Perform cell culture activities, maintaining aseptic techniques to support cell-based assays.
- Maintain Data Integrity and ensure compliance with SOP’s and cGMP requirements.
- Participates in Lab Operation Activities including Inventory management, CAL/PM coordination, stocking of labs and assistance with equipment PMs.
- Support continuous improvement projects in the QC Laboratories such as 6S and Kaizen.
- Assists in writing, reviewing, and revising SOPs.
- Performs analysis and interpretation of test results, and data trending, identifies deviations, and makes appropriate recommendations.
- Participates in the peer review of QC Test Data.
- Participates in method and equipment qualification/validation studies; generates protocols, executes, coordinates assays, and drafts reports.
Qualifications
- Relevant scientific degree with minimum 2-5 years of Quality Control experience in a bio-pharma analytical laboratory.
- Experience with mammalian cell culture is required and insect cell culture is a plus.
- Experience with cell-based assays required.
- Experience with qPCR, SDS-PAGE methods is a plus.
- A strong background in molecular biology is desired.
- Experience with viral vector (adeno-associated virus) product is a plus.
- Knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industries desired.
- Must have laboratory experience with a variety of analytical techniques including, but not limited to, quantitative and/or digital PCR, ELISA, and cell-based methods.
- Knowledge of statistical methods applicable to the analysis of experimental data.
- Proficient in general and non-routine laboratory skills.
- Excellent interpersonal, communication and organizational skills.
- Flexibility in problem solving to meet business objectives. Good oral and written communication skills.
- MS Office skills; equipment related software such as ImageLab, QuantStudio 6, Soft Max Pro desired.
Pay
Why Choose R&D Partners?
As an employee, you have access to a comprehensive benefits package including:
- Medical insurance – PPO, HMO & HSA
- Dental & Vision insurance
- 401k plan
- Employee Assistance Program
- Long-term disability
- Weekly payroll
- Expense reimbursement
- Online timecard approval
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal-opportunity employer.