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Quality Compliance Manager Resume Example

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JC
Jessica Claire
, , 100 Montgomery St. 10th Floor (555) 432-1000, resumesample@example.com
Professional Summary

Dedicated Quality Compliance Manager with over 6 years of quality management professional experience and over 10 years of laboratory experience. Knowledgeable regarding FDA 21 CFR parts 4, 11, 58, 111, 117, 210, 211, 700, 701, 820, 1300 and corresponding regs for ISO 13485. An exceptional eye detail and a knack for devising and establishing effective quality procedures, standards, policies and specifications. Quality integrity driven, methodical and skillfully strong at executing hands-on quality engagement from the laboratory and throughout the operations of the organization. Skilled trainer focused on quality systems and technical tasks. Experienced auditor performing internal and vendor inspections. Maintains and safeguards organization's products by strategically implementing process controls and performing risk-based analyses from start to finish. Enthusiastically motivated and powered by growth and challenges, channels motivation to fellow departments by promoting the power of "quality" through interdepartmental forces.

Skills
  • Prepared and currently maintaining company's quality program to follow Code of Federal Regulations Title 21 PART 117 for cGMP Practice, Designed & Maintain [HACCP] Hazard Analysis, and Risk Based Preventative controls for human food; Part 111 for Dietary Supplements; Part 700 for Cosmetics; Part 701 Cosmetic Labeling
  • Influentially maintains, engages, motivates, interacts, mentors, audits, monitors, counsels executive team, laboratory operations to warehouse production operations over Quality regulatory essentials for cGMP and other regulatory demands; thrives off of interdepartmental gains through teamwork and collaboration
  • Narrates, executes and ensures compliancy with Standard Operating Procedures, policies, guidance documents and other Quality documents with strong reporting and documentation skills to meet quality and legal compliance
  • Extremely detail oriented, analytical with ability to always comprehend and depict "big picture" scenarios
  • Proficient with detailed Root Cause Analyses and strategic planning to ensure corrective actions are implemented within procedures and processes in pursuit to streamline mishaps from repeating
  • Plans and coordinates for routine quality audits as well as internal mock audits and mock recalls to forming company's recall program
  • Strategically implements quality maintenance plans such CAPAs, Material Reviews, Deviations Justifications, Change Request Notifications, Document Control and OOS
  • Skillfully troubleshoots customer complaints and handles any major quality matters that may require external communication on behalf of quality
  • Highly influential and very compassionate by nature; outstanding communicator, exceptional listener and overall naturally easy with interpersonal skills
  • Proficient ability to distinguish hazard and/or other risk analyses
  • Rallies fellow department and interdepartmental peers, strategically prepares and successfully leads all quality audits such as health department inspections, FDA visits, organic certification, kosher certification, GMP certification, preparing for GFSI's BRC audit and other third party certification demands including second party related audits per customer and vendor demands
  • Fluent in Chinese (Cantonese)
Work History
08/2020 to Current Quality Compliance Manager Cb Richard Ellis | Berlin, WI,

Responsible for all aspects of the quality compliance including:

  • Management of the quality management systems and documentation including: CAPAS, Change Controls, Facility and Equipment Qualification, Process Validation, Procedures, Document Control monitoring, Customer Complaints, Management of non-conforming materials from receiving to in-house products
  • Maintenance and improvement of the QMS in accordance with ISO 13485:2016.
  • Internal audit program design and implementation in accordance with ISO 13485:2016
  • Participation of in the supplier quality management
  • Compliance training for Quality members, Production Management and Quality/Regulatory onboarding for all incoming employees including production operators
  • Improve quality processes for increased efficiency and effectiveness.
  • Developed and deployed production control plans, including creating all related work instructions and procedures.
12/2014 to 08/2020 Director of Quality Control and Laboratory Operations Alchemy Aromatics DBA The Perfumery | City, STATE,
  • Responsible for directing activities that support and monitor quality essentials for portfolio of over 1000 products by overseeing daily operations in Quality Control and laboratory operations
  • Responsible for creation of effective Quality Systems within the company: Material Review Systems and lead the Material Review Board, Out of Specifications System, Corrective and Preventative Action [CAPA], Customer Complaints System and the Deviation Justification System; creating and executing HACCP Plan
  • Ensures compliance to company policies, set up Quality Systems within the company and ensure that the team abides by the set standards set, as well as other regulatory and quality organizations and standards, and cGLP best practices, cGMP, under the Code of Federal Regulations TITLE 21 Parts 111, 117, 700 & 701
  • Ensures compliance with all applicable regulations, standards, systems, procedures and practices, ranging from FDA, Organic, Kosher, Whole Foods through the Indiana State Health Department certifications
  • Co-plan and Co-execute with CEO and COO, Inventory Control, Operations Manager, Controller, Sourcing and other leadership roles to ensure on-going compliance and product quality
  • Reviews and audits departmental documents for appropriate distribution and filing
  • Drafts and approves standards, specifications and procedures for processes, facilities, products and tests
  • Determines the identity and content in material within inventory portfolio and biomass from original material to ensure product integrity
  • Maintains compliance with FDA and other certifying bodies
  • Leads the Department of Health's proficiency studies
  • Collaborates with business units for cost model analysis
  • Established analytical test methods and assurance for data integrity
  • Developed products and technologies that met product performance, quality and timing requirements
  • Cultivate methods to screen for analyses through via 3rd party connections
  • Analyzes and monitors team analytical chemists' organic compounds to determine their chemical properties
  • Conducts quality control tests and directed test procedures
  • Drafts standards and specifications for processes, facilities, products and tests
  • Organizes due diligence in preparation for setting up Quality Systems and directing all members of the company to follow Quality procedures through training and maintaining to following up when the procedures are deviated
  • Initiated a program that standardized product refinement system by setting up procedures and work flows to increase interdepartmental information for the financial, inventory control, laboratory to quality and supply chain management
  • Builds strategic alliances with the quality teams of clients that resulted in confidence within company's not only quality standards but also boosted revenue
  • Responsible for narrating, authorizing and approving: standard operating procedures, raw specifications, forms, master manufacturing records, safety data sheets, manufacturing work flows, certificate of analyses
  • Issuing statements on behalf of company's quality department for: Natural Certification, FSMA, Allergens, IFRA, NON-GMO, Pesticides, Origin, Kosher and Organic Certification
  • In the process of Organic certifying the facility and the product inventory
  • Routine audits for interdepartmental batch records, labeling and other record keeping to ensure everything meets quality standards
  • Manages retained sample handling, receiving, storage and inventory
  • Develops, maintained and improved experimental data spreadsheets
  • Certified through NSF's Vendor Qualification and Auditing
  • Certified through NSF's 21 CFR 111 Dietary Supplement Group
  • Set up control processes in manufacturing operations for preliminary, in progress, hidden damage and final product inspections
  • Monitors production operations for compliance with specifications and promptly reported defects
  • Identifies and helps resolve non-conforming product issues
  • Collects samples during production and tested randomly to determine in-process product quality for audit purposes
  • Inspects outbound shipments and conducted random sampling to ensure product quality for audit purposes and daily operations
  • Performed frequent visual inspections to root out tolerance and compliance issues
  • Rejects defective products and approved correct products
  • Implemented quality control processes with critical control points throughout company
  • Collaborates with CEO and COO to develop scopes and implement project plans
  • Trains, coaches and mentors staff to ensure smooth adoption of newly merged quality program
  • Maintains work peers' allegiance and trust by being involved and always available and having a "hands-on" management style
04/2011 to 11/2014 Analytical Chemist & Laboratory Manager Microbac Laboratories, Inc. | City, STATE,
  • Analyzed organic and inorganic compounds to determine their chemical properties
  • Maintained laboratory instruments and developed new laboratory equipment
  • Conducted quality control tests and directed test procedures
  • Routinely calibrated scales to minimize leakage due to calibration errors
  • Determined equipment operating efficiency
  • Interpreted test results and developed nonstandard tests
  • Drafted standards and specifications for processes, facilities, products and tests
  • Ordered chemicals for analysis and prepared reagents for analysis
  • Maintained compliance with DEC and EPA
  • Set up standards for sampling analysis and data interpretation using effluent analysis
  • Developed products and technologies that met product performance, quality and timing requirements
  • Maintained records and quality documents for drinking water and A2LA audits
Education
Expected in 2006 Bachelor of Arts | Biology University of Louisville, Louisville, KY GPA:
Expected in 2008 Bachelor of Arts | Sociology University of Louisville, Louisville, KY GPA:
Extracurricular Activities

    Louisville Regional Science & Engineering Science Fair

    [March 2010 - Present]

  • Judge and Mentor
  • YWC, The Younger Woman's Club of Louisville [August 2011- Present]

  • Lifestyles Chairperson (2014 to 2016) - responsible for hosting club's annual philanthropy benefit Fall into Fabulous Fashion Show
  • Louisville Film Society [January 2016 - Present]

  • Member and Co-host of official Oscar Watch for Louisville
  • Speed Art Museum [October 2016 - Present]

  • Board of Governor [October 2016 - Present]
  • 2017 Patron Circle Committee Member, The Bacchanal
  • 2018 Patron Circle Committee Member, The Bacchanal
Certifications

HACCP - Hazard Analysis Critical Control Point Coordinator

  • May 2019 - Current

PCQI - Preventive Control Qualified Individual

  • January 2019 - Current
BUSINESS REFERENCES:

Mrs. Susan Taylor

Corporate Controller

The Perfumery, LLC

621 Park East Blvd

New Albany, IN 47150

Mobile: XXX-220-1663

Mr. Aaron Sorensen

Chief Executive Officer

Aromatic Plant Research Center (APRC)

230 N 1200 E

SUITE 100

Lehi, Utah 84043

Mobile: 812-406-3297

Mr. David Lester

Managing Director

Microbac Laboratories

3323 Gilmore Industrial Parkway

Louisville, KY 40213

Mobile: XXX-442-4062

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Resume Overview

School Attended
  • University of Louisville
  • University of Louisville
Job Titles Held:
  • Quality Compliance Manager
  • Director of Quality Control and Laboratory Operations
  • Analytical Chemist & Laboratory Manager
Degrees
  • Bachelor of Arts
  • Bachelor of Arts