Senior Associate II, QC Bioanalytical

Description

The Senior Quality Control Associate – Bioanalytical is responsible for assuring valid and timely test results are provided per applicable internal procedures. Senior Quality Control, Bioanalytical performs routine and non‑routine product testing using written analytical methods. The Senior Associate also provides training and guidance to QC Associates as needed to ensure compliant laboratory operations. Additional responsibilities include assisting with transferring analytical methods from development into the QC laboratory and test method validation.

Generate test results and report results for the assigned GMP testing in a timely and compliant manner. Perform and validate analytical methods such as HPLC assay, Capillary Electrophoresis assay, Spectroscopic assay and/or other analytical techniques in a GMP environment with minimal supervisory guidance.

• Assure complete and correct GMP documentation of laboratory testing using forms, logbooks, and laboratory notebooks and summarizing of test results per SOP’s and FDA regulations.
• Contribute to investigations into testing failures, identification of root causes and implementation of corrective actions.
• Initiate change control requests and oversee associates with revision of documents, qualification of new equipment/system or changing configuration of existing equipment/system.
• Use technical expertise with Bora Biologics Test Methods and SOPs to guide the lab personnel.
• Assist in improving QC operations as assigned by manager, including revising analytical method and equipment SOPs.
• Perform peer review of test results.
• Initiates and performs QC responsibilities such as sample coordination, lab equipment maintenance, QC document management, QC inventory control and reconciliation of sample requests/documents as needed.
• Perform independent assignments such as:
  • Compile data for documentation of test procedures and preparation of reports.
  • Review documents and author standard operating procedures (SOPs).
• Author Technical Reports as needed
• Conduct routine and non‑routine analyses of GMP products as assigned by the manager using appropriate biochemical methods such as: HPLC, Capillary Electrophoresis, CE‑SDS, UV‑Vis etc.
• Maintain and monitor laboratory equipment for temperature and conformance to specifications.
• Apply acceptable cGMP practices during execution of all work tasks
• Work independently with moderate supervisory guidance.
• Exhibit strong teamwork skills
• Update manager of progress on a frequent basis. Seek additional guidance as needed.
• Perform analytical method transfers, analytical method validation and testing product GMP samples as assigned.
• Other duties as assigned that may include raw materials testing or facility support

• BS or advanced degree in chemistry, biology, biochemistry or related life sciences discipline with at least 3 years’ experience in Quality Control within GMP biopharmaceutical or biotechnology industry.
• Recent Quality Control/Analytical/Method Validation experience with Biologics strongly preferred.

• Working knowledge of GMP regulations.
• Knowledge of validation of HPLC, Capillary Electrophoresis, immuno‑assays, and/or other analytical techniques in a GMP manufacturing facility is desirable
• Experience in QC product tests, such as in‑process and finished products testing is desirable.
• Knowledge of using chromatographic instrumentation and associated software is essential.
• Knowledge of statistical analyses for bio‑analytical assays is important.
• Ability to write technical documents, Test Methods, SOP’s, Validation Protocols and Reports etc.
• Ability to adapt, work flexibly, and thrive in a highly collaborative environment
• Ability to work in a fast‑paced, environment.
• Strong attention to detail.
• Capable of being organized and managing multiple projects and responsibilities simultaneously.
• Knowledge of Microsoft Office suite (Excel, Word, PowerPoint).
• Excellent oral, written, and interpersonal communication skills.