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Quality Manager Resume Profile

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Objective:

To obtain a full-time position within the Manufacturing Industry that will effectively utilize my knowledge of Quality Assurance, Food Safety, 21CFR Regulations, Quality Control, Microbiology, Chemistry, Laboratory Supervision and Management, Root Cause Analysis, cGMP's, cGLP's, Quality Systems, Global Food Safety Standards and HAACP to make a positive contribution toward meeting organizational goals and objectives.

Career Summary: Experienced Food Safety and Quality Assurance Management Professional with over five years of experience in USDA and FDA inspected facilities. Also proficient at managing conflict, negotiating and setting priorities. Experienced gained working primarily in the food , pharmaceutical and consumer goods manufacturing industry. An accurate, hard worker recognized as a self starter and go to person to solve quality issues. Able to work on own initiative and as part of a team. Experienced in problem solving, root cause analysis and collaborative interactions with operations, sales and customers. Able to assess product performance and assure continuous improvement. Dedicated to maintaining high quality standards

Confidential

QUALITY MANAGER

Duties: Ensures compliance with all quality programs including GMP and HACCP manages HACCP program continuously evaluates quality systems and submits recommendations ensures proper staffing of the Quality Department facilitates all internal, third and regulatory agency auditing and inspections coordinates and manages the pest control program manages the allergen control program maintains Safe Quality Food SQF standards and compliance communicates and quality issues with other departments as needed.

Confidential

QUALITYASSURANCE SUPERVISOR

Duties: Acts as a high-level technical resource for interpretation of policy reviews/approves technical documents decision making for the quality unit as well as the site Quality oversees activities involved in the review and release of finished product with a focus on compliance to company polities and regulatory standards provides leadership during regulatory inspections and external audits approves change controls and deviation reports review/approves validation protocols/reports conducts cGMP training with staff and ensures staff is current manages customer complaints revises/reviews/approves SOP's, OOS's, CAPA's performs internal quality audits

Accomplishments:

  • Supervised twelve 12 direct reports
  • Implemented weekly Quality Assurance Departmental meetings
  • Revamped/redesigned the entire internal audit program to achieve a higher level of compliance
  • Developed a quality system of delegating and assigning workload in the department which resulted in an increase in productivity within the department

Confidential

QUALITYASSURANCE SPECIALIST / CORPORATE SQF PRACTITIONER

Duties:Responsible for all Quality Control functions at 3 production facilities and a company owned farm. Ensures federal, state and local compliance in regards to food safety and quality. Ensures the proper application of 21CFR. Maintains QC programs and documentation kosher certificates third party audit certificates, etc . Assists in FDA, USDA, state and third party audits. Ensures customer specifications are met. Investigates and responds to customer complaints. Member of the Food Safety Team. Maintains Nutritional Database and responds to customer requests for Nutritional Panels. Serves as a Corporate SQF Practitioner overseeing the successful implementation of SQF level 2 standard for three production facilities.

Accomplishments:

  • Achieved SQF Level 2 with a certification with an excellent rating at all three production facilities two years in a row meeting our largest customer requirement. Responsible for implementation including gap analysis, developing and updating company programs, delegating responsibilities to plant management and verification to assure all SQF requirements are met. Passed 6 SQF audits with excellent ratings.
  • Implemented a verification and validation process for allergen change over procedures.
  • Restructured all internal specifications programs. Created updated copies used frequently by QA, Sales and Customer Service Departments.
  • Resolved food safety and quality issues daily.
  • Initiated training with Customer Service Department which resulted in consistent data entry with consumer complaints. This in turn lead to better data collection and trending which was then reported to Senior Management.
  • Managed audits conducted by FDA, USDA, ODA, and customers
  • Member of the Food Safety Committee and Management Review Committee.

Confidential

SENIOR MICROBIOLOGIST

Duties:Performs test/product development activities test/project development scheduling document generation i.e. drafting protocols, reports, SOPs, etc. coordinates and performs client sponsored studies related to the pharmaceutical and medical device industries such as population verification, AOAC disinfectant efficacy testing, biological indicator inoculation, bacterial filtration efficiency testing, microbial identification and more analysis and interpretation of data calculation of results report review and signing assures the accuracy and timeliness of technical reports works directly with clients ensures cGMP compliance with laboratory and laboratory documentation.

Accomplishments:

  • Drafted SOPs and worksheets and developed test methodology for AOAC Use-Dilution and Tuberculocidal Activity testing.
  • Project Manager for Packing Validation client study involving accelerated and real-time shelf life studies, packing integrity study, seal peel test, and burst test.
  • Authored final report for client BI stability study
  • Executed IQ/OQ protocol for Spectrophotometer

Confidential

ADJUNCT INSTRUCTOR

Duties: Demonstrated the use of appropriate teaching techniques Demonstrated the use of appropriate testing and grading procedures, including proper maintenance of grade books and any other appropriate record-keeping requirements Demonstrated the effective use of oral and written communication skills and knowledge of current procedures in the Biology field Followed approved curriculum standards and course syllabi Advised and counseled students and maintained appropriate advisement records on each student Attended meetings as required Observed and enforced the institution's policies and regulations Maintained qualifications for employment as described by accreditation standards Followed rules and regulations as described by the Department of Allied Health and other policies and procedures established by the institution.

Confidential

QUALITY ASSURANCE DEPARTMENT LAB SUPERVISOR

  • Duties: Performed quality control laboratory functions in full compliance with cGMPs Supervised the day-to-day activities of eleven analytical technicians, microbiological technicians and incoming goods technicians Conducted appropriate OOS investigations following systematic root cause analysis approach to identify and implement corrective actions Managed laboratory instrumentation to ensure continued compliance to the Quality Program and cGMPs Responsible for training and motivation of the laboratories Motivated self-starters that can work independently with minimal supervision Controlled the laboratory budget Gave technical advice to production managers, Demonstrated a team work ethic. Accomplishments:
  • Solved major quality assurance problems which temporarily halted production
  • Redesigned the company's environmental monitoring program
  • Implemented weekly laboratory meetings to encourage better internal communications
  • Produced monthly reports for CEO and Senior Management concerning lab analysis that will help produce better yields
  • Supported customers through resolution and corrective action of Quality issues that reduced customer complaints
  • Drafted and directed the revision of all departmental Sop's for improved documentation
  • Completed FDA certified Better Process Control School training
  • Used MiniTab/Excel to provide data analysis that resulted in streamlined product specifications
  • Familiarized with LIMS and SAP systems

Confidential

MICROBIOLOGIST

Duties: Performed all required microbiological analysis on raw materials, bulk batches, and finished products Performed challenge studies Maintained required cultures Prepared necessary media and reagents Maintained records on media and equipment Worked with outside testing labs when required Performed general lab analytical procedures Performed environmental sampling and analysis Trained compounders and warehouse personnel on proper sampling technique Trained chemists on micro methods as needed Performed all testing in an cGMP compliant manner and performed related duties as assigned.

Accomplishments:

  • Investigated an increased frequency of Pseudomonas detection within the facility. This included finding the root source and collaboration with Quality Management and maintenance workers on the proper disinfection of equipment
  • Trained a technician in USP and BAM microbiological methods and procedures for routine testing and organism identification
  • Assisted in resolving issues of tank cleaning, disinfection, and validation of those procedures
  • Learned new lab techniques such as Celsis Rapid Detection

Confidential

FOOD MICROBIOLOGIST/ QC TECHNICIAN

  • Duties: Ensured products were produced to meet or exceed consumer requirements routinely sampled products to ensure the safety of the product conducted analytical tests on incoming raw ingredients as well as final whipped cream products performed failure testing followed GMP's, HAACP guidelines, and all safety rules explicitly inspected product completed appropriate testing worksheets communicated with appropriate personnel maintained lab and lab equipment and performed related duties as assigned. Accomplishments:
  • Conducted independent research into the detection capabilities of a handheld ATP bioluminesce microbial detection system to determine the appropriate microbial alert and action levels
  • Gained industry experience
  • Learned new lab techniques such as viscosity and dry solids testing

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