SHRYLON “SHELL” SIMS

PROFILE

Senior level Quality Control Analyst offering 17 years of proven performance in quality control and quality assurance in the biotechnology-pharmaceutical industry.

Environmental Monitoring

Quality Control for In-House & Final Products

Quality Assurance Planning & Scheduling

Preventative Maintenance Shutdowns

Sample Management & Verification

Quality Control Laboratory Auditing

LIMS

Supervision

Test Record Evaluation & Verification

Performed supervisory review of documentation

Performed visual and dimensional inspection of labeling

Insured cGMP

Deviation Investigation Reporting

DEA Regulations

CFR Regulations

OSHA Regulations

EXPERIENCE

AMGEN, INC. Fremont, CA

Manufacturing Specialist (11/10 to 01/11): Perform assigned tasks to achieve company goals and department objectives. Conducted investigational meetings to complete and close nonconformance reports for manufacturing programs. This position is a contract assignment, assigned through Kelly Scientific Services.

Utilized the Electronic Document Management System( EDMS)

Used the Sharepoint Program platform

Performed routine check of the database to ensure nonconformance data for the Manufacturing Programs were accurate and current.

CELL GENESYS, INC. South San Francisco, CA

Quality Control Analyst III (3/2002 to 10/2008): Assisted in directing the environmental monitoring program of the manufacturing facility, laboratory facilities and utility systems, which chiefly involved planning and scheduling preventative maintenance shutdowns, ordering and tracking laboratory reagents and materials, and performing data entry and tracking of in-process materials and final products. Performed microbial assays and microbial identification for in process and final products. Conducted and performed microbial techniques such as bioburden testing, preparation of stock cultures, aseptic technique, pipeting technique, LAL testing, and reagent preparation. Performed visual inspection of containers, and packaging components such as vials, stoppers, caps. Prepared samples for shipment to contract laboratories and monitored the tracking of all samples that were sent out for testing. Managed and verified samples upon receiving from various departments (Research &Development, Manufacturing, Validation, and Raw Materials). Generated and maintained logbooks for sample management and laboratory equipments and laboratory support functions. Collaborated with the vendor representatives to maintain laboratory instruments and testing equipment. Performed all duties and responsibilities in compliance with standard operating procedures, Safety Quality Identity Potency Purity (SQUIPP), regulations outlined in the Code of Federal Regulations (CFR), Occupational Safety and Health Administration (OSHA) and other applicable Federal, state and local regulations. Additionally, performed and tracked routine maintenance and calibration of laboratory equipment, audited quality control laboratory equipment, and used the Document Management System (DMS) to initiate and revise documents. Initiated and completed investigational reports of environmental deviations (EDRs), deviation reports (DRs) and corrective action/preventive action reports (CAPAs). Defined Standard Operating Procedures for the use and maintenance of laboratory equipment. Demonstrated comprehensive knowledge of cGMP requirements for raw materials and finished products.

Assumed control over scheduling the environmental monitoring program, and properly planned environmental testing of ISO 5, 7 and 8 areas to ensure timely, complete, non-duplicative testing.

Perform GMP compliance checks in manufacturing and associated operations

Supported internal and external audits and worked with internal departments and outside vendors to accomplished goal commitments.

Serve as the Quality representative on cross-functional and multi-site teams

Performed technical review of material Certificate of Analysis certifications.

Reduced the rate of deviation reports from 1-2 quarterly to 1 semi-annually, immediately minimizing costly product delays associated with investigating and resolving the deviations.

Worked with external departments to ensure the timely inspection and release of material lots for use in the GMP manufacturing process.

Worked with the Validation Team to implement and complete change control request for laboratory equipment.

Utilized QUMAS management program to implement new and revised standard operating procedures for the Quality Control Department.

Collaborated with the Quality Assurance department to identify process discrepancy root causes and implemented effective corrective actions.

Implemented and provided guidance, support, and direction towards the aseptic techniques and optimization of the GMP manufacturing process.

Effectively organize and lead project teams and deliver results

Narrowed the turnaround to release in-process materials, reducing delayed releases from 50% to less than 5%. To achieve this, opened communication and ensured even distribution of work among senior and less senior Quality Control specialists.

Minimized incidence of incorrect documentation from 75% to 15%, in large part through providing comprehensive training that emphasized proper document and test record review procedures that included verifying the results.

Computer skills with working knowledge of Microsoft Word, Excel and PowerPoint.

Utilized Microsoft Access to the database system.

BAYER HEALTHCARE Berkeley, CA

Quality Control Associate Scientist (1/2001 to 3/2002): Principally guided the validation of in-process materials, raw materials, and final products using KQC-LAL and Gel Clot test methods. Provided training, and orchestrated the Quality Control specialists’ schedule for conducting environmental monitoring of the manufacturing facility, laboratory facilities and utility systems. Implement process improvements and corrective actions in response to adverse trends identified from the analysis of this data. Evaluated, verified and released test records. Upheld cGMP practices. Functioned as the chief liaison with vendor representatives.

Supervised six or more Quality Control Specialists daily activities.

Identify, design, and implement process and system improvements.

Captured a $10K annual savings by applying manifold filters already in use in another area of the lab to expand testing of 1 WFI sample to simultaneous testing of up to 8 samples.

Repeatedly selected by management to conduct advanced training for other analysis, particularly on e-coli testing and deviation reporting.

Assist in audits related to Manufacturing and QC production issues.

Exchange information with employees, peers, and management regarding quality issues. Serve on the Material Review Board to support the Nonconformance Control System and participate in the production meetings to ensure schedules are met.

Quality Control Analyst I-III (8/1992 to 12/2000): Mastered and performed environmental testing of the manufacturing facility, conducted microbiological testing of in-process materials and final product. Utilized aseptic techniques throughout all GMP manufacturing processes. Performed animal testing for in-process materials and final products. Conducted training for less senior quality control analysts and colleagues.

EDUCATION

MS, REGULATORY AFFAIRS FOR DRUGS , BIOLOGICS, AND MEDICAL DEVICES, COMPLETION AUG 2011

Northeastern University, BOSTON, MA

BA, ORGANIZATIONAL MANAGEMENT, CONCENTRATION: BIOLOGY

Ashford University, Clinton, IA 2008

BS, BIOLOGY

Southeastern Louisiana University, Hammond, LA

Relevant Coursework: Inorganic Chemistry, Physics, Microbiology, Biology, Anatomy, Physiology, Nutrition

COMPUTERS

Microsoft Word, Excel, Access, PowerPoint,

Certificates

PTI- Writing Reports for Failure Investigations and Process Deviations August 2004

PTI- Achieving and Maintaining Laboratory cGMP Compliance March 2006

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