Become A Quality Control Associate

* Performs the accurate execution of any and/or client test methods and procedures of cellular products to ensure the Safety and/or Efficacy of different cell populations
* Perform maintenance, monitoring, and trouble shooting of pertinent equipment
* Test, document and report results for products or materials for Clinical Trial supplies following client procedures and CGMP & GTP
* Successfully, perform state proficiency testing and/or client proficiency testing under direct supervision as applicable
* Participate in managing QC materials and supplies; Ordering of materials; Manage and monitor the use of materials
* Perform and assist in equipment and method validations as needed; Reagent and Media Preparation
* Able to provide input based on level of knowledge and experience to trouble shoot equipment malfunctions and investigate out of specification and/or non-conforming test results
* Initiate, investigate and prepare deviation reports with input from supervisor in a timely manner and implement corrective actions, preventive actions
* Communicate effectively with other co-workers, departments, management and clients.
* Additional tasks as assigned by the Quality Assurance Management

* Conducts routine and non-routine HPLC analysis according to standard operating procedures to support in-process, release, and stability testing in a manner consistent with cGMP requirements.
* Compiles data for documentation of test procedures in a manner consistent with GDP requirements.
* Analyzes data and results and presents conclusions to supervisor in tabular, graphical, and written format.
* Reviews data obtained for compliance to specifications and reports abnormalities to supervisor.
* Assists in the transfer, qualification, and validation of new testing methods with guidance from supervisor, which may include writing protocols and reports.
* Assists in investigations related to deviations and out of specification results.
* Initiates revisions to current SOPs and authors new SOPs based on methodology being transferred into the QC laboratory.
* Responsible for standardization and maintenance of laboratory equipment and maintains lab area.
* Embodies Althea's cultural values by aligning daily actions with department goals and company culture.
* Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices

* Perform testing using aseptic technique in a laminar
* Airflow Clean Bench Per Procedures Maintain all Documents for Laboratory
* Analysis Perform rapid sterility testing per procedure and
* report results per cGMP/GLP Guidelines Identify OOL results and follow the guidance of
* supervision through investigation process Receiving, storage, and logging in samples for testing
* analysis Maintain the daily cleanliness of the laboratory Maintains Supply Inventory for Laboratory Orders Supplies and other materials Follow Standard Operating Procedures Maintenance of Laboratory Documents
* Support
* in all regulatory inspections: FDA, DEA, Board of Pharmacy, and Internal

* Review notebook documentation, raw data and other documentation at an extremely detailed level for accuracy, consistency and completeness
* Ensures sample data are documented in a manner that is compliant with GLPs, protocols and SOPs.
* Reviews all data (notebook documentation, raw data, and LIMS data), study reports, assay validation reports and other documentation in a timely manner to meet project timelines.
* Identify and communicate findings in a clear and concise manner and verify appropriate corrections have been made.
* Follow GLPs and internal procedures (SOPS, working practices

* Perform chemical, biochemical, biological and/or microbiological testing, assays and procedures related to quality control (QC) by following Standard Operating Procedures (SOPs) in order to obtain results that allow for release of patient product(s).
* Document performance of analytical methods in order to be consistent with current GMP and documentation practices.
* Support creation of analytical method protocols and reports to support method development, method qualification, stability study, and assay optimization in collaboration with PI and QC project lead.
* Adhere to cGMP compliance requirements to maintain inspection-ready state.
* Collect, interpret and perform basic analyses and reporting of data from test results.
* Recommend modifications for optimization or clarification of test procedures, protocols, and assays in collaboration with quality control, quality systems management, Principal Investigator (PI) and project team.
* Manage, maintain, monitor, and order QC raw materials and supplies
* Monitor and troubleshoot pertinent equipment; Ensure equipment qualification, preventive maintenance, and calibration are performed per requirement and by due date.
* Coordinate equipment implementation for use and decommissioning activities.
* Participate in the investigation of out-of-specification and/or non-conforming test results.
* Prepare deviation reports per SOPs with input and oversight from supervisor.
* Implement prevention or corrective actions based on supervisor feedback.
* Participate in the development and maintenance of QC related SOPs, test procedures, training records, and other QC-related documentation.
* Perform QC Support tasks – e.g. equipment maintenance, tracking of reagent and sample inventory, organization of the lab, checking to ensure removal of expired media performed, etc.
* Coordinate the timely shipment of samples to contract laboratory for testing (e.g. ship samples such as environmental monitoring plates for growth promotion, speciation and product sample).
* Other duties may also be assigned
* Qualifications