MLM Medical Labs · 9 hours ago
Quality Assurance Associate - Contract
Memphis, TN
Full-time, Contract
Onsite
Entry Level
2+ years expMLM Medical Labs is seeking a Quality Assurance Associate I to oversee QA processes and conduct QA activities. The role involves maintaining standards for testing, identifying areas for process improvement, and ensuring compliance with Good Clinical Laboratory Practices (GCLP).
BiotechnologyMedicalPharmaceutical
No H1B
Hiring Manager
Daniel Exley
Responsibilities
Controlled Document Program (SOPs, assay procedures/experimental worksheets, forms associated with SOPs, equipment forms and records; Duties include tracking documents for CLIA visits/schedules and vendor scheduling/servicing)
Revise, create, and implement measures to ensure documents are controlled per written processes and retained according to applicable regulations and internal procedures
Schedule, manage, and track revisions and/or retirement of controlled documents according to internal procedures
Maintains files according to internal procedures
Schedules CLIA visits on calendar for applicable management and laboratory staff
Maintains all records and various laboratory licensure which meet global expectations
Archive Program
Revise, create, and implement measures to ensure the archival program is robust and meets regulatory and internal expectations
Ensure study specific records, facility/equipment records, and regulated training records are stored, managed, and indexed to facilitate expeditious retrieval for health authority inspections and internal audits
Training Records Program
Revise, create, and implement measures to ensure training records are managed to meet regulatory and internal expectations
Liaise with Human Resources Department to implement holistic measures to maintain records which meet global expectations
Inspection Readiness Program
Revise, create, and implement measures to ensure MLM Medical Labs maintains continual readiness for health authority inspections
Maintain tracking logs for inspections, procedures, and manuals that enable the recreation of inspections
Additional Duties
Maintain and write a variety of records, reports, and correspondence with a high degree of accuracy and efficiency
Identify and respond to organizational issues, concerns, and needs
Assist as position may require with data review or statistical analysis
Maintain knowledge of scientific trends and industry processes through readings, conferences, and seminars and reviewing literature to enhance or improve QA procedures and methods
Perform related duties as assigned
Perform laboratory duties as determined by management
Documentation of study-specific activities will be recorded and tracked to prevent any conflicts of interest with regulated duties
Regulatory Acknowledgement
Adhere to and uphold all applicable federal and state compliance regulations as well as internal compliance policies and standard operating procedures, accrediting agency policies and procedures, and applicable healthcare fraud, waste, and abuse laws
Abide by all MLM Medical Labs’ policies and standards
Qualification
Required
Bachelor's degree from accredited institution in life science, chemistry, pharmaceutical science, statistics, or health/human services related field
Equivalent to two (2) years of related professional experience in laboratory services or translational sciences in the pharmaceutical industry
A solid foundation of knowledge in Quality Assurance and Quality Management principles
Significant and demonstrated knowledge of laboratory equipment, product use, and terminology
Statistical / qualitative data analysis skills
Excellent problem-solving and analytical skills
Excellent time management and multi-tasking skills
Excellent computer skills with knowledge of spreadsheet, word processing, and statistical analysis software
Ability to function independently, exercise good judgement, and work in a team-based environment
High degree of reliability and professionalism
Company
MLM Medical Labs
MLM Medical Labs is a leading specialty and central laboratory with comprehensive research services and diagnostic capabilities in Europe and the United States.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2020-10-26Acquired
Leadership Team
Scott Houlton
Chief Executive Officer
Company data provided by crunchbase