Host FDA and client audits and assist with inspections of routine processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures.Perform data and document (SOPs, protocols/batch records) reviews to assess that records follow ALCOA++ and are in compliance with all applicable regulations, international standards, and corporate policies and procedures.Conduct facility and process inspections of the testing facility.Review technically complex data and processes for accuracy and compliance with all applicable requirements and standards.Participate in development of corrective and preventative actions and process improvements in response to client and regulatory audits.Given the responsibility to establish and execute a Quality Management System (QMS) for a new start-up GMP Cryo-electron Microscopy Biosafety Level 2 (BSL2) laboratory.Author, revise, and approve SOP’s and forms for the new laboratory.Oversee supplier qualifications and supply channel approvals.Provide GMP and Data Integrity training to all staff engaged in GMP operations.

Lead QA team in qualifying and enrolling all materials for site.Oversee supplier qualifications and supply channel approvals.Perform Product and Material Release.Obtain and review supplier assessments to qualify suppliers.Identify deviations from established standards and serve as Quality Assurance approver for investigations.Independently comprehend and document appropriate corrective/preventative actions (CAPA) designed to mitigate Quality deficiencies identified in the investigative process.Write, approve, and /or implement changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.Perform review/release of raw materials and packaging components.Review master batch records, labels, specifications and other pre-production documents.Aid in the development of Quality Operations processes.Execute batch record issuance and disposition to support release of manufacturing batches.

Enroll all materials for the entire Pfizer Sanford site.Complete supplier qualifications and supply channel approvals.Review audit reports to guarantee compliance. Work independently implementing and maintaining quality systems with respect to Document Management, Training, Investigations, corrective/preventative actions (CAPA), Change Controls and Compliance.Review supply channels, place supply channels under evaluation, and approve supply channels.Review, write, and gather information for QA investigations.Assist with writing risk assessments to assess the risk of materials to be used on site.Assess activities related to Supplier Management and assessment of initial and continued services.Contribute to continuous improvement of systems and processes.

Review, write, and gather information for manufacturing investigations for terminally sterilized products.Conduct and drive closure of non-conformance events to identify root cause, product impact, and preventative actions for Manufacturing Operations in support of batch disposition and continuous process improvement.Work cross-functionally with various departments/management to obtain an in-depth understanding of products and documentation requirements.Independently comprehend and document appropriate corrective/preventative actions (CAPA) designed to mitigate Quality deficiencies identified in the investigative process using quality tools (Fishbone, 5 Why’s, DMAIC method).Complete investigations and CAPAs in alignment with established procedures and timelines.Demonstrate strong technical writing and problem-solving skills.Provides technical assistance to area supervisors and managers to solve complex problems.Proficient in global Quality Tracking System (gQTS).

Clean in Place (CIP), and operate process equipment that includes bioreactors, mixing columns, and ultrafiltration skids (UF Skids).Revise Standard Operating Procedures (SOPs) and Batch Records (BRs).Execute Ramon Flocculation (Lf) assay to determine tetanus toxoid concentration (for EP compendial method verification and in-process stat testing).Oversee and motivate team in day to day operations on the Manufacturing floor.Review Batch Records and Equipment History Logs.Compound buffers and formulate ethanol buffers.Steam in Place (SIP) process equipment that includes bioreactors, portable vessels, ultrafiltration skids, and WFI drops.Experience with deviations, root cause analysis, and Corrective Action/Preventive Action (CAPA) implementation.Assist with implementing 5S in the work areas.

Operate Industrial Autoclaves and washers for sterilization.Utilize calibrated scales to weigh out dried components and use graduates and flasks to measure liquids.Clean in Place (CIP) process equipment that includes chromatography columns.Train new employees on documentation procedures by following area Standard Operating Procedures (SOPs) and providing detailed written and verbal instructions in order to complete assigned tasks.Contribute to a successful Process Verification (PV) campaign with C. Diff (clostridium difficile).Demonstrate and instruct proper aseptic gowning and aseptic processing procedures.Use Delta-V, LIMS, and SAP systems to perform daily duties.

Operate equipment and execute processes (i.e., Autoclaves, Equipment Washers, Stopper Processors, portable tank processing, CIP skids, testing filters, and assembling components) in accordance with Standard Operating Procedures.Perform all duties in a manner consistent with cGMP, safety, environmental, human resources, and FDA policies and procedures.Utilize Delta-V, MES, and SAP systems to perform daily duties.Work in a team environment to accomplish departmental goals.Effectively communicate equipment and process status during daily tier meetings.

Enters new patient profiles and prescriptions into the medication input software system. Works closely with pharmacists and uses medication input software to safely and accurately dispense medication.Answers and screens phone calls for the staff pharmacist in a friendly, efficient manner.Regularly completes paperwork and enters prescriptions and insurance billing information into patient profiles.Maintains proper inventory levels, rotates stock, and immediately complies with prescription drug recalls.Communicates directly with doctors’ offices via telephone and fax.Coordinates patient care by maintaining accurate health records and effectively resolves insurance rejections and other billing issues.Fills prescriptions by retrieving prescription orders: counting, pouring, measuring and weighing medication tablets, liquids, and creams.

Prepared and loaded catalyst samples into two Micro reactors to test catalyst elements over a wide range of conditions while performing internal quality control procedures throughout experimentation to insure a high level of data integrity.Executed internal quality control procedures throughout the experimentation to insure a high level of data integrity.Carried out daily preventative maintenance and weekly inventory audits.

Supervised a team of laboratory technicians in properly analyzing finished goods and raw materials by chemical, physical, and instrumental means.Performed validation testing on equipment to maintain proper operating parameters, reviewed batch records, and performed root cause investigations.Prepared all standards and reagents needed for proper execution of analytical methodsMaintained accurate and precise records of all laboratory analyses and instrumental documentation. Complied with GMP and cGMP in an FDA and OSHA regulated industry.Reported results quickly while multi-tasking, understanding the timely nature of work, and changing priorities quickly.Assisted with laboratory cost savings program.

Managed a team of laboratory technicians in properly preparing blood components while complying with GMP and cGMP in an FDA and OSHA regulated industry.Assisted and performed routine procedures following Standard Operating Procedures, Blood Service Derivatives, and Local Operating Procedures.Quarantined unacceptable blood to be discarded.Labeled acceptable blood to be released for distribution.Maintained updated laboratory records to comply with regulatory requirements.