BioLife Laboratory Validation Associate is responsible for qualification and/or validation of equipment, computerized systems, and laboratory processes. Validation activities include research, protocol writing/execution and final report generation. Additionally, investigations of laboratory challenges are conducted and process improvements are evaluated / implemented. Ensures compliance with regulations and proper documentation. Presents change controls and protocols to auditors.
1.Development and completion of documentation on protocols, including test cases and final reports.
2.Manage documents and follow-up on validation projects including: new equipment selection, acquisition, installation and use, facility/system/process improvements, modifications and additions, and computer-based systems and software.
3.Organizes and performs the logging and archiving of validation documents.
4.Assist in the creation of validation protocols and requalification programs.
5.Coordinate/perform the test activities necessary to execute the validations.
6.Reviews/summarize the results and conclusion of the validations.
7.Coordinate any software control activities used in the manufacture, testing approval, or documentation of the product.
8.Performing technical failure analysis on processes/product not meeting specifications.
9.Developing statistical process control programs to monitor processes.
10.Reporting on trends to reduce product/process variability.
11.Apply statistical analysis and design of experimental approaches to process development activities.
12.Works on moderate to complex problems where analysis of situations or data requires an in-depth evaluation of various factors or intangible variables.
13.Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
14.Serves as project lead with projects of intermediate scope and cross-functional teams.
15.Stays current with federal, state, local, company-specific all other applicable regulations.
16.Provides interpretation and application of regulatory requirements concerning validation activities.
17.Support regulatory submissions and regulatory agency inspections as required.
18.Participates in audits of laboratory operations, documents audit findings and reports results to Laboratory Quality Assurance Manager and Director of Laboratory Operations.
19.Works with laboratory management team to prepare for and host internal and external auditors. Assists laboratory management team to ensure timely closure of audit observations.
20.Assists with and/or advises on laboratory procedure development and implementation as requested or necessary to support continuous improvement. Performs periodic review and or validation of SOPs as needed.
21.Maintains familiarity with laboratory operating and quality assurance/quality control procedures and quality system regulations and standards in order to effectively perform laboratory quality assurance functions.
22.Maintains current and accurate records of all relevant communications, audits, corrective action plans, and effectiveness monitoring.
23.Performs revisions to Standard Operating Procedures as assigned.
24.Supports/Participates in change control management and CAPA systems.
25.Participate in operational excellence initiatives and projects to drive a culture of continuous improvement to achieve site operational excellence.
26.Other duties as assigned.
EDUCATION AND EXPERIENCE
Minimum Degree Required:
Bachelor degree from an accredited college/university in a biomedical or technical discipline (Chemical, physical, biological, clinical lab science, medical technology, engineering, computer science, or mathematics)
Bachelor degree from an accredited college/university in Medical Technology.
Minimum of three years professional or technical experience in a laboratory, blood services or pharmaceutical manufacturing, including significant exposure to the regulatory requirements affecting that discipline or activity.