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Tanvex CDMO is Now Bora Biologics · 1 week ago

Senior Associate II, QC Bioanalytical

San Diego, CA

Full-time

Onsite

Mid, Senior Level

$75K/yr - $91K/yr

3+ years exp

Tanvex CDMO, now known as Bora Biologics, is seeking a Senior Quality Control Associate - Bioanalytical responsible for ensuring valid and timely test results in a GMP environment. The role involves performing routine and non-routine product testing, providing training to QC Associates, and assisting in method transfers and validations.

Pharmaceuticals

Responsibilities

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

Qualification

HPLCCapillary ElectrophoresisGMP regulationsAnalytical Method ValidationTechnical WritingMicrosoft OfficeTeamworkAttention to DetailCommunication Skills

Required

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

Working knowledge of GMP regulations

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

Preferred

Recent Quality Control/Analytical/Method Validation experience with Biologics strongly preferred

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