La'Kisha Randolph
Columbia,MD
Summary
Dedicated and knowledgeable Quality Assurance Manager with over 20 years of experience in the biopharmaceutical industry and skilled in various areas of current QA methodologies. Obtained leadership and training experience. Delivers in-depth competencies within FDA GLP, GMP, GCP, and GCLP regulations; possesses extensive experience in internal/external audits, raw data and report reviews, Bioanalytical audits, Method Validations, Equipment Validations (IQ/OQ/PQ), NCA reports—experience writing, revising, and reviewing SOPs and hosting Client Audits.
Overview
23
23
years of professional experience
Work History
SR. QA Manager, GLP
Amador Bioscience Inc.
04.2022 - Current
- Collaborate with system owners, SMEs, facilities, compliance, IT, bioanalytical scientists, and management to establish modern laboratory operations functions focusing on compliance, efficiency, and improvement. I host weekly meetings to discuss any issues related to quality and compliance and how to improve or present a plan to work towards steps needed to complete the goal.
- Support quality systems covering pre-clinical studies (GLP) and laboratory clinical (GCLP) testing activities for monitoring study activities, bioanalytical assays, facilities, equipment validations/maintenance, procedures, and pertinent records for Good Laboratory Practice regulations and company’s standard operating procedures. This is achieved in several ways: weekly meetings with the SME, emails with the timelines from the project managers, working groups, quality committees, quarterly reports to management, roundtable meetings, and training.
- Support laboratory compliance efforts in collaboration with the laboratory compliance team and site leadership. Weekly meeting with
- Review, revise, and create SOPs in ACE (eDMS).
- Responsible for managing and training a team of auditors with different experience levels.
- In-process inspections of study phases, raw data, final reports, and internal facility audits are conducted per FDA GLP, protocol, and SOPs and reported and submitted to PI/SD and TFM/TSM.
- Host Client audits
QA Specialist
Lentigen Technology/Miltenyi Biotech
11.2017 - 04.2022
- Revised material specifications and updated supporting supplier documentation files and part number documentation to meet regulatory expectations (GMP Part 210 & 211).
- Inspected raw materials to verify quality and disposed of items that did not meet safety requirements
- Conducted and assisted in Supplier Quality audits, including material and supplier qualification. Performed audits of their facility following regulations and procedures, issued audit reports, and communicated findings to management.
- Reviewed, revised, and created SOPs in Master Control (eDMS).
- Reviewed and assessed change notifications received from Suppliers.
- Reviewed and approved GMP documents, such as batch records, to ensure compliance with specifications, regulations, and SOPs.
QA Specialist III
Technical Research International Inc.
07.2016 - 04.2017
- Assessed Sponsor and Investigator, monitored compliance with protocol, good clinical practice (GCP), and applicable regulatory requirements and relevant human subject protection regulations, policies, and procedures.
- Planned, scheduled, and conducted audits at clinical sites.
- Documented and performed internal audits and other QA activities.
- Supported document management system (eDMS).
- Prepared audit reports to communicate outcomes of quality activities and reported them to management.
- Ensured compliance with industry standards and regulations through diligent adherence to established QA procedures and guidelines.
- Assisted in root cause analysis investigations, leading to more efficient problem-solving techniques within the team.
- Facilitated effective communication between QA, development, and management teams through regular status updates on ongoing projects, including progress reports and issue-tracking metrics.
QA Specialist III/Manager
MedImmune/AstraZeneca
07.2008 - 12.2015
- Assured that findings of nonclinical study data and bioanalytical clinical study data collected in support of products regulated by the FDA complied with appropriate GLP regulations, protocol, and MedImmune’s SOPs. Performed in-process inspections of study phases, audits of raw data and final reports, and audits of internal facilities; summarized audits in written report format and submitted findings to the principal investigator, study director, and management; established and maintained QA files and records.
- One of my key responsibilities was to perform initial and periodic vendor audits and assessments. These audits, conducted with meticulous attention to detail, were crucial as they included a thorough review of policies, procedures, and gaps in GLP regulations (FDA, MHLW, and OECD). Furthermore, I also conducted in-process and raw data inspections of studies contracted to vendors, ensuring that the quality of these studies met our high standards.
- Supervisory duties included training and overseeing the QA consultants' workload at the CA sites (I was the sole FTE for two locations: Hayward and Mountain View).
QA Associate III
PDL BioPharma
02.2007 - 07.2008
- Planned, conducted, and reported FDA GLP inspections and audits of external vendors, and internal PDL facilities.
- Performed in-process inspections of study phases, audits of raw data and final reports, and audits of internal facilities; summarized audits in written report format and submitted findings to the principal investigator, study director, and management; established and maintained QA files and records.
- Developed, delivered, and documented comprehensive GLP training programs for PDL personnel that supported GLP activities and provided external training, as needed.
- Supervised, trained, and guided junior GLP QA staff as directed by GLP Management.
Senior Quality Research Auditor
MPI Research Inc.
12.2001 - 01.2007
- Implemented independent assessments of protocols, laboratory procedures, data, facilities, and reports, to determine the level of compliance with applicable FDA GLP, OECD, EPA, MHLW, SOPs, and study protocols.
- Prepared accurate, concise, and written reports of actual and perceived deviations from GLPs, SOPs, and protocols for submission to Study Directors and Management for corrective actions and review.
- Independently, I was responsible for all assigned studies, including attendance at all study meetings to determine necessary phases to be inspected, assuring required inspections are performed, preparing reports of inspections, maintaining Master Schedule, and providing peer training on various topics concerning lab inspection and procedures.
- Played a key role in helping a new department (Experimental Therapeutics) become GLP compliant.
Research Technician- Small Animal
MPI Research Inc.
05.2001 - 12.2001
- Facilitated the administration of a variety of test materials, including pharmaceuticals, chemicals, and biological substances, to small animals such as mice, rats, guinea pigs, and rabbits.
- The test material was administered intravenously, subcutaneously, dermal, intrascapular, gavage, and intramuscularly.
- I performed data collection (observations, body weight measurement, and food consumption), animal husbandry, and data review. I also acted as the Lead Technician in various studies.
- Studies ranged from 1 day to 2 years, with the number of animals ranging from 20 to 2,000.
Education
Bachelor of Science - Zoology
Michigan State University
East Lansing, MI05.2001
Skills
- Auditing
- Regulations (GLP, GMP, GCP, OECD, EPA, CLP)
- NCA report audits
- Bioanalytical analysis audits
- Equipment Validation (IQ/OQ/PQ)
- Method Validation audits
- Leadership
- Works independently
- Data Validation
- Quality assurance methodologies
- Employee Training
- Quality Assurance Management
Timeline
SR. QA Manager, GLP
Amador Bioscience Inc.
04.2022 - Current
QA Specialist
Lentigen Technology/Miltenyi Biotech
11.2017 - 04.2022
QA Specialist III
Technical Research International Inc.
07.2016 - 04.2017
QA Specialist III/Manager
MedImmune/AstraZeneca
07.2008 - 12.2015
QA Associate III
PDL BioPharma
02.2007 - 07.2008
Senior Quality Research Auditor
MPI Research Inc.
12.2001 - 01.2007
Research Technician- Small Animal
MPI Research Inc.
05.2001 - 12.2001
Bachelor of Science - Zoology
Michigan State University
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