Quality/Project Manager

Senior Quality Control Professional with extensive experience in the Biopharmaceutical industry. Thorough understanding and application of cGMPs in labs and manufacturing operations. 18+ years experience in directing, managing and guiding teams to meet FDA regulations and corporate requirements. Extensive working knowledge of microbiological procedures, such as microorganism identification and sterility testing for final container. Extensive experience in product stability operations and its various facets. Experience working with toxic potent compounds while ensuring product safety and employee protection. Strong communication and leadership skills. Extensive documentation and training experience. Outstanding experience as a Food Safety professional within the Food industry.

PROFESSIONAL EXPERIENCE

Pacific BioLabs Inc. Hercules, CA 2008-Present

Microbiology and Sterility Assurance Manager

Leadership role in the department by structuring and coordinating staff testing activities, playing a lead role in the hiring and training of new staff, participating in the review and approval of protocols and special projects requested by clients or initiated to improve the efficiency of the laboratory.

• Developed, implemented, and maintenance of systems to ensure that clients receive top-notch service

• Ensured that routine microbiology testing and information are met in a timely and effective manner. Developed specialized studies based on pertaining standards and guidelines such as those found in AAMI/ISO/ANSI, ASTM, USP, EU, and ISO and also make sure that these studies comply with applicable regulations including cGMP, GLP, and Quality Systems

• Ensured that client complaints are effectively and professionally dealt according to PBL standards.

• Created Sterilization and Cleaning Validation protocols for the Medical Devices and Health industries based on sound, scientific information and applicable standards. Directing GLP studies for toxicological assessment. Provided direction and interpretation of cell cytotoxicology and hemolysis studies and LAL testing.

• Played a lead role in departmental designed to improve the internal efficiency and overall quality of work performed in the laboratory. Played a lead role in maintaining an atmosphere of teamwork and professional growth by both technical expertise and managerial skills.

• Developed EM programs for clean and controlled rooms in accordance with ISO and USP standards. Sterility testing for product release and investigation of OOS.

• Managed client and regulatory audits including responses to audit observations and recommendations. Directing corrective actions in response to observations.

• Maintained working knowledge of current industry standards and practices pertaining to microbiological and sterility assurance testing of the pharmaceutical products and medical devices. Maintained thorough knowledge and understanding of all SOPs and their updating to new or revised standards and regulations.

• Helped the department to structure and organize the efforts in all areas related to testing, such as reporting, data review, test conduct, test preparation.. Monitored the progress of testing as required and investigation of deviation notices and OOS.

Novartis (acquired Chiron Corporation) Emeryville, CA 2001 - 2007

QC Stability Specialist (Interim-Manager) 2003 - 2007

Supported formulation department to initiate the stability studies for different projects resulting in all studies including (testing and scheduling) adhering to FDA regulations. Defined the expiration dates for individual products so products were still compliant.

• Coordinated stability studies for pre-clinical and clinical products. Pre-approved stability plans and testing schedules for protein based products and small molecules.

• Reviewed analytical data such as HPLC, SDS-PAGE, pH, etc for conformance with specifications in SOPs and compliance with ICH stability and USP guidelines. Input, verified, and managed the database including entering new results and studies. Prepared data summaries and stability reports for various scientific projects and/or products to recommend re-testing dates or expiration dates.

• Acted as interim manager during the Chiron-Novartis Inc. company integration for the stability studies, ensuring a successful transition and smooth operation without postponing studies and/or testing.

• Ensured compliance with cGMPs, and 21CFR 210 and 211 in the ICH, FDA, and internal requirements, and guidelines for all stability operations and plans.

• Directed the workflow for 35 employees including Scientists, in the Drug Delivery and Formulations department and acted as the GXP coordinator to assure conformance with 21CFR-Part 58 and Chiron requirements. Developed training plans and folders for employee. Audited labs and equipment.

• Supervised the small molecule weight and dispense lab. Monitored weight and dispense activities according to cGMPs and BPR (batch product records).

• Participated in making the potent compound weight and dispense lab cGMPs compliant. Wrote new SOPs. Ensured compliance with cGMPs such as Environmental monitoring, cleaning schedule, procedures and documentation.

• Collaborated in cGMPs clinical campaigns for potent compounds in bottles and capsules. Formulated API and excipient. Co-monitoring the manufacturing of clinical supplies for patients in Phase 2.

• Assisted in surrogate testing and validation of new equipment such as tablet press, capsule filling, and isolators for potent compounds. Provided cleaning procedures for equipment when used with potent compounds. Followed validation protocol for the testing of the equipment.

• Power user of Atlas submissions and computer validation script tester. Trained employees within the Product Process Development department to use the search engine and program, Atlas Submissions, for IND and clinical reports and data. Proofed validation scripts for new computer programs for the entire company.

Supervisor, Quality Assurance Microbiology 2001 - 2003

Managed a team of nine analysts who conducted microbiology testing and supervised the testing process according to SOPs, FDA regulations and which ensured all results provided to customers passed regulations and prevented corrective actions.

• Hired, trained and supervised nine analysts performing the various tests for in-process, release, and stability samples which ensured compliance with cGMPs, SOPs, testing procedures, and safety regulations.

• Prepared midterm and annual employee performance assessment for promotion and salary rate increase.

• Performed troubleshooting during testing, developed testing schedules and approved training for new employees and also training due to revision of SOPs.

• Conducted routine lab inspections that improved operational efficiencies.

• Reviewed and released test results for commercial and clinical operations to ensure compliance with specifications. Initiated proper actions depending on results, products, and customers. Maintained and updated database with accurate information.

• Responsible for discrepancy reports and out of specification investigation and corrective actions in the microbiology lab.

• Supported EM operations in cGMP areas. Oversaw Microbiology Analyst plate reading. Performed troubleshooting plate reading.

• Partnered with various departments including Environmental Monitoring for the initiation of action, alert, and discrepancy reports. Exercised corrective and preventive actions in the laboratories.

• Prepared and revised SOPs. Updated and documented procedures due to observations, annual revision, improvement, and discrepancy report.

• Participated in audits from regulatory agencies, customers, ISO, and in-house inspections. Conducted pre-inspection of labs and made recommendations for corrective actions. Enforced corrective actions and preventative actions from audit observations.

• Exercised corrective and preventative actions in labs. Worked with analysts and managers to resolve DRs.

H.J. Heinz company (formerly Cornucopia), Irvine, CA 1990 - 2001

Quality Assurance and Food Safety Director

Directed and managed a team of 25 employees within the QA and Food Safety departments. Responsible for updating and implementing cGMPs guidelines. Designed and developed various QA and Food Safety strategies to meet business goals, quality specifications and food safety regulations resulting in the manufacturing of thousands of gallons of finished goods for major clients such as Sizzler, CPK, Applebee’s, Marie Calender’s, and Chevy’s.

• Guided, mentored and trained a team within the QA and Food Safety departments including two managers and 23 QA and QC technicians and continuously monitored their performance and adherence to regulations and internal quality specifications.

• Developed and implemented Quality programs for QA and QC functions which increased product quality and process control.

• Created documentation, processes and procedures to control raw materials including management of the database tracking system which resulted in meeting compliance.

• Created and wrote product specifications for 100+ products and produced the Certificate of Analysis (COAs) reports which met compliance for all customers.

• Initiated and managed QC labs for chemical, physical, and microbiological testing. Appointed a Microbiologist as head of the labs to oversee daily activities. Supported operations for troubleshooting and technical questions. Adherence with product specifications. Oversaw training of new technicians.

• Created First Generation Hazard Analysis and Critical Control Points Program (HACCP).

• Built the 1st Food Safety department and worked together with Manufacturing and other departments to create workflows and made recommendations on how to apply the newly created (HACCP) program based on scientific approaches and FDA regulations. Certified in HACCP.

• Supported new product formulation and assisted development in bringing new recipes by providing expertise in cooking, cooling, and storage temperatures according to regulations. Tested products and produced shelf life studies.

• Responded to out of compliance reports from FDA and USDA including corrective and preventative actions. Responded to observations and complaints from customers.

• Planned and executed internal and external audits. Created inspection templates based on cGMPs and scheduled inspections. Led multidisciplinary teams to perform audits.

• Coordinated employee training. Created training records for all employees from cGMPs, OSHA, and basic microbiology. Created training templates and schedules. Led training for hundreds of employees over an 11-year period. Customized training courses for new hires.

EDUCATION

California State University, Fullerton, CA

MS in Chemistry with emphasis in Biochemistry 2000

Thesis: “Ceruloplasmin mRNA and Copper in Mammary Gland During Pregnancy and Lactation in Rats”

PUBLICATIONS

Dominguez, D., Donley, S., and Linder, M.C.; Rapid Incorporation of Radioactive Copper in Mammary Gland, Milk, and Milk Ceruloplasmin during Lactation in Rats; The FASEB Journal; 1998; Volume 12 Number 5 Part II (1161)

Linder M., Dominguez, D., Wooten, L., Donley, S., Hallock, M., Copper Transport and Ceruloplasmin during Lactation and Pregnancy; 1999; Metals and Genetics; pp 117-129; Kluwer Academic/Plenum

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