Laboratory Manager/ Product Engineer Resume

SUMMARY

Good knowledge and understanding of compilation, tracking, and processing regulatory documents
Strong understanding of Drug and Medical devices regulatory submissions: IND, BLA, NDA, eCTD, 510K and PMA.
Comprehensive knowledge of ethics and regulations in clinical research, ICH guidelines and FDA regulations and guidance.
Working knowledge of Quality Compliance in pharmaceutical and medical laboratory environment, while reviewing and creating Standard Operating Procedures for Coagulation Assay procedures, safety regulations, and various other guidelines required by CAP (College of American Pathologists)
Provide guidance to laboratory technologists about the medications that the patients would be on and how it would affect their laboratory test results and assessing whether higher dose of medicine can have serious adverse events. Provide counseling to the doctors accordingly.
Experience handling the pharmaceutical data for drugs with detailed knowledge of ICH, GMP and GLP guidelines
Excellent teamwork, leading, communication and interpersonal skills. Fast learner and well prepared for the challenges faced in a fast pace environment

TECHNICAL SKILLS

Databases: MedDRA (Drug Safety), PubMed (Literature)

Tools: Microsoft Office, Acrobat Professional, SharePoint.

Methodologies: cGMP guidelines, FDA regulations for pharmaceutical and Medical devices industries, ICH guidelines, HIPAA Regulations, and CAP (Center of American Pathologists) regulations

PROFESSIONAL EXPERIENCE

Laboratory Manager/ Product Engineer

Confidential

Responsibilities:

Support on - site laboratory audits and walkthroughs to ensure procedure compliance.
Working on various projects simultaneously with shifting priorities to meet project deliverables -which includes correspondence with EHS (Environment Health and Safety) committee for helping the site transition from ISO 14798 to ISO 45001 certification while working with the entire Laboratory Diagnostics (LD) team.
Keep track of laboratory inventory and ensure the inventory is replenished
Order lab supplies including consumables, reagents and instrument parts
Ensure that the instruments are replenished with consumables and reagents
Schedule in-house instrument repairs and maintenance when required
Adhere to company and regulatory compliance procedures
Schedule the laboratory resources when personnel needs to utilize automation system or instruments
Ensure that the laboratory safety procedures are followed by engineers
Execute the test cases in the laboratory and fill out EPRs when an issue is encountered while performing the test cases.
Within EPR (Engineering Problem Reports) run a thorough investigation working with the developers to find out the root cause and precautions to prevent from happening again.
Work on CAPA investigations and perform regression and related verification testing as well as related documentation- such as Verification Report, Traceability Matrix Tables, Issue Summary Reports and Design Verification Plans.

Senior Medical Technologist / Medical Writing

Confidential

Responsibilities:

Worked on various regulatory operational activities such as e-CTD submission requirements with Medical Writing team.
Facilitated in researching and resolving technical and operational problems, whether it is related to validating the instruments, correlations, or establishing the quality control ranges for new reagents and methodologies.
Directly worked with Quality Systems Team to deal with investigations and fill out CAPA forms, and work on the preventative actions as well as troubleshooting.
Performed Special Coagulation testing, such as General Thrombophilia (GT) panel, Lupus Inhibitor, Factor deficiencies and various pregnancy tests related to blood clotting disorders.
Worked with Lab Supervisor and Director to create laboratory protocols tethered based on new projects and implementations of laboratory guidelines.
Worked with Quality Systems department for submission of documents during CAP and FDA inspections, and ensure the readiness of laboratory in terms of compliance.
Carried out daily and weekly instrument maintenance, reagents preparations, Lavey-Jennings, Quality Control, and calibration curves to ensure accurate results.
Trained new Lab technicians and Medical Technologists on various Coagulation tests, laboratory guidelines, ICH and FDA governing procedures and HIPAA regulations.

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