SUMMARY

• Savvy, results - oriented leader with proven success in managing a multi-billion dollar company in the Pharmaceutical / Nutraceutical industry.
• Critical thinker and adept manager who can apply extensive industry knowledge.
• Background includes supervising all cross training in the department on all phases of documentation, production, job duties, safety policies, security measurements, resulting in 0% increase in errors and any deviations within two weeks of transferring over into the department.
• My unique combination of manufacturing and quality experience gives valuable strength to any operations company looking to improve its effectiveness and manufacturing efficiency.
• Proficient in CFR 21 Parts 111, 210 and 211. Lean and Kaizen Proficient. Keen knowledge of aseptic awareness.

PROFESSIONAL EXPERIENCE

Confidential, Santa Ana, Ca

Production Supervisor

Responsibilities:

• Trained, developed oversaw day-shifts production staff. Conducted regular on time performance appraisals and gave continuous performance feedback and disciplinary actions when appropriate.
• Ensured that food and GMP practices were followed and employees were handling the manufacturing of food in conformance with regulations and company standards.
• Ensured that pre- requisite programs for food safety were in compliance.
• Assisted in the planning, direction and coordination of the production process to ensure a continuous flow of quality food that meet or exceeded all requirements of the customer, company and regulatory agencies.
• Assisted Bakery Director with fulfillment of daily production requirements.
• Communicated with Bakery Director prior to the start up of each shift.
• Ensured a safe and sanitary facility that meets or exceeds all requirements of the customer, company and regulatory agencies.
• Encouraged and maintained effective communications in all areas and between all levels within the bakery.
• Supported company policies and procedures and modeling behaviors from others to learn from.
• Participated in safety programs and brings safety awareness down to the levels of the workers.
• Maintained a variety of records to accurately reflect schedules, performance, time recording, daily production, ingredient usage, verification of documentation, etc.
• Participated in company audits and regulatory controls.
• Sanitation responsibilities as well.

Confidential

Production Supervisor

Responsibilities:

• Prioritizes the work load for the department to meet production commitments for 30 employees. Prepares daily work schedules in alignment with the activities of other manufacturing departments. Assigned daily duties to operators to optimize resources and achieve production objectives. Worked closely with the V.P. of Operations and the V.P. of Special Ops/Technical Services.
• Inspects and approves equipment/rooms after cleaning procedures are completed to verify equipment and facilities meet cleanliness requirements.
• Audited all logs throughout the shift to ensure they were properly filled out per GMP.
• Created and administered employee performance reviews reflecting achievements and noting areas of improvement for continued development.
• Monitors department staff attendance and provide counsel to employees when the number of incidents exceeds company guidelines in ADP.
• Develops and revise Standard Operating Procedures for area of responsibility.
• Assisted in the 5s of the facility.
• Constantly audited all documentation within the department for any errors on a daily basis and prior to any Q.A. and FDA visitors arriving to the facility.
• Sanitation responsibilities as well.

Confidential

Sanitation Supervisor

Responsibilities:

• Prioritizes the work load for the department to meet production commitments. Prepares daily work schedules in alignment with the activities of other manufacturing departments.
• Developed and implemented a plant wide Master Sanitation Schedule.
• Developed and implemented (JI’s) Job Instructions for all equipment including production and Compounding facilities.
• Provides leadership to insure the practices and conditions create a safe working environment. Conducted regular training sessions of Safety, GMP's and SOP's with department staff to ensure compliance and awareness. Provide other training as required with ECOLAB.
• Developed and revised Standard Operating Procedures for area of responsibility.
• Assisted in Kaizen and Lean activities within company.
• Maintained all proper documentation to demonstrate compliance with all audits.
• Supported Pest Control ( Orkin ) program including all biweekly inspections.
• Acquired cleaning equipment to support and improve the sanitation including spray balls, tanks and pumps that can handle different cleaning detergents.
• Worked closely with all QA and QC teams to ensure all swabbing was conducted prior to proceeding with production.

Confidential

Tableting Supervisor

Responsibilities:

• Prioritizes the work load for the department to meet production commitments within a 50 member staff group. Prepared daily work schedules in alignment with the activities of other manufacturing departments. Assigns daily duties to operators to optimize resources and achieve production objectives.
• Supervises, trains, and develops department staff to insure process control and efficient operations.
• Inspects and approves equipment/rooms after cleaning procedures are completed to verify equipment and facilities meet cleanliness requirements.
• Audit the weighing and staging process to ensure that the correct raw materials are used and in correct amounts as specified in the Ingredients Batch Record.
• Audited all cleaning logs throughout the shift to ensure they were properly filled out per GMP.
• Performs regular inspections of the department's facilities and equipment to ensure compliance with cGMPs, and Safety requirements.
• Develops and revise Standard Operating Procedures for area of responsibility.
• Assisted in Kaizen and Yellow Belt activities within company. Yellow Belt Certified.
• Sanitation responsibilities as well.

Confidential

Unit Dose Supervisor

Responsibilities:

• Under general supervision, managed and focused a 50 member staff in the performance of the Weigh Up, Blending, Compression, Encapsulation, Coating, Grinding and Inspection departments daily work requirements.
• Revised batch records and SOP's as required.
• Performed responsibilities associated with department hiring, training, problem resolution, work assignment delegation and attendance tracking.
• Applied effective implementation of employee disciplinary corrective actions programs.
• Conducted performance evaluations for hourly employees.
• Worked with temp agency’s to ensure correct staff was being interviewed prior to assignment.
• Investigated testing abnormalities and implemented corrective action.
• Prepared daily reports for upper management on a daily basis.
• Sanitation responsibilities as well.

Confidential

Senior Lead

Responsibilities:

• Under general supervision, managed and directed staff in the performance of the Compounding departments and Weigh Up departments daily work requirements.
• Monitored departmental facilities and equipment ensuring they were used and maintained in a safe, clean and sanitary condition as per Confidential guidelines.
• Trained all employees on the cGMP’s. Ensured that Confidential was “Tour Ready” at all times.
• Responsible for initiating and accomplishing solution to corrective actions resulting from audits and changeovers.
• Assumed role as acting Supervisor when Supervisor was unavailable.
• Sanitation responsibilities as well.

Confidential

Technical Associate Lead

Responsibilities:

• Reviewed and approved all plasma receiving inspection.
• Prepared and submitted samples to Q.C. for testing and sent out samples for outside testing.
• Confirmed test results with Raw Material Specifications.
• Assisted in closing out audit findings by identifying the root cause and suggesting an appropriate corrective action.
• Assisted in the validation of processes in the manufacturing department.
• Performed departmental review of procedures, cGMPs, SOPs and initiated DCR’s for changes including new processes that were validated from the validation department.
• Responsible for training employees in new processes.
• Assumed role as acting Supervisor when Supervisor was unavailable.
• Sanitation responsibilities as well.

Confidential

Process Technician

Responsibilities:

• Operated processing equipment including autoclaves, ovens, vial washers, and depyrogenation tunnel.
• Performed CIP and SIP of tanks along with the Annealing and Sterile Filtrations of products.
• Operated vial capper, unloaded product from lyophilizers, and packed off unloaded vials from lyophilizers and liquid fill line.
• Worked with Sartocheck 3 Filter Integrity Tester, pH Meters, Nephelometry and Conductivity Meters.

Confidential

In Process Lab Supervisor

Responsibilities:

• Wrote and revised SOPs, cGMPs, MSPs and LMPs.
• Resolved technical, material and procedure problems that may have impacted project deadlines.
• Managed the continual audit of all documentation (50 logbooks) in the department for any errors prior to any Q.A. and FDA visitors arriving to the facility.
• Obtained DEA clearance along with all other necessary security measures in the department.
• Supervised all cross training in the department on all phases of documentation, production, job duties, safety policies, security measurements, resulting in 0% increase in errors and any deviations within one month of transferring over into the department.
• Held the role of Formulation Chemist. Synthesized Active Pharmaceutical Ingredient. Executed final product distillation on Pope Scientific Molecule in a clean room environment following cGMPs. Performed final product sampling.
• Analyzed in-process material on an Agilent Gas Chromatography system.
• Ensured proper implementation of laboratory policies and procedures, applicable safety regulations and instructions through direct supervision and document review.
• GC, HPLC Column Chromatography and Rotavapor experience.