Quality Assurance Manager
Resume:
MCINNIS MCKENZIE
Plantation, FL 33324
Email: *.**********@*****.***
949-***-**** (Cellular)
PROFESSIONAL PROFILE:
Senior Manager of Quality Assurance and Control departments with over 20 years of experience from the
start-up of new laboratories, quality departments to established laboratories which support release of raw
materials, in-process and Finished products. I have managed the transfer of Test Methods and SOPs
serving the Biotech/Pharmaceutical/Medical Device industries. Strengths include technical knowledge,
organizational abilities, team building, assertive follow-up, and risk assessment management skills.
PROFESSIONAL EXPERIENCE:
Validant Consulting Firm (Lead Consultant) for QC Method Validation / QA Review
06/2013-Present
As a Lead Consultant, I must exercises judgment within defined practices and policies in selecting methods,
techniques and evaluation criteria for obtaining results. Exhibit excellent verbal, written and interpersonal
communication skills are required. This position requires an in depth understanding and application of
principles, concepts, practices, and standards. In this role, you must be able to work on problems ranging
from moderately complex to complex in scope where analysis of situations or data requires in-depth
evaluation of various factors, strong judgment is required in resolving problems and making
recommendations.
Coordinate and perform audits across both internal/external manufacturing platforms. Identify
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compliance risks and report findings to appropriate management with recommendations for resolution.
Work directly with operating entities to ensure completion of corrective actions to address compliance
concerns identified during audits.
Demonstrate the ability to incorporate sound Risk Management fundamentals in the establishment
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and adherence of audits conducted across the commercial manufacturing base. Participate in the
development, implementation and maintenance of programs/ processes to assist in ensuring compliance
with current Good Manufacturing Practices (cGMP) expectations.
Maintain audit schedules to ensure quality oversight of contract manufacturers, contract laboratories
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and internal functions. Promote awareness across the commercial and clinical manufacturing platform of
current regulatory agency requirements.
Develop and present auditor training modules to client staff and mentor team auditors. May
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coordinate and interface with regulatory agencies as required in support of regulatory agency inspections
Essential Duties and Job Functions:
Manages compliance audits and may manage QA consultants. Leads compliance audits. Performs
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a wide variety of activities to ensure compliance with applicable regulatory requirements. Participates in
developing Standard Operating Procedures to ensure quality.
Maintains Quality Assurance programs, policies, processes, procedures and controls ensuring that
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performance and quality of products conform to established standards and agency guidelines. Provides
expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to
assure compliance.
Works directly with operating entities to ensure that inspections, statistical process control analyses
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and audits are conducted on a continuing basis as specified to enforce requirements and meet
specifications.
Ensures compliance with current Good Manufacturing Practices (cGMPs) and Good Laboratory
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Practices (GLPs). Interfaces with contract manufacturers to address documentation and compliance issues.
May interface with regulatory agencies as required.
Duties/ Responsibilities:
! Perform QA Review and Approval of Method Assessment and Risk Assessment protocols and
reports generated for analytical and QC test methods.
! Review will ensure that the protocols are written in accordance with corporate SOPs and have
sufficient technical detail for scientists/analysts to accurately execute them and ensure that the studies meet
current industry standards, and assure that reports accurately demonstrate a compliant analytical test
method.
M & M Consulting Firm
Corporate Quality Assurance, Quality Control & Regulatory
Affairs
03/2011- Present
Working with global leader in the manufacturing of pharmaceuticals, generic injectables and
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medical devices. The company's mission is to play a role in the transformation of the quality and
compliance in the pharmaceutical, generic and medical device industries through focusing on one
objective, which is the
customer.
Consultant for Teva Parenteral
Medicines
MicrobiologyDepartme
nt
11/2011- 09/2011
Duties / Responsibilities:
Coordinate the activities of the assigned functional group/department. Assist in establishing
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operational objectives, goals and project assignment. Develop and implement team metrics to accomplish
established objectives and goals. Administer and recommend changes to policies which affect the
department. Departmental subject matter expert.
Coordinate the activities of a functional area or department with responsibility for results in terms of
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costs, methods and employees. Ensure that all the activities of the Microbiology lab related to the
functional area are executed in a timely and efficient manner by scheduling, planning, and coordinating
the activities of direct reports. Coordinate all/certain areas of the lab function. Provides guidance to
supervisors and other department members.
Train and mentor direct reports. Approves and release appropriate documentation for assigned
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testing for direct reports in a timely manner. Assure that the testing and documents are in compliance with
cGMPs and SOPs.
Work on and solve increasingly complex projects/problems where analysis of situation or data
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requires evaluation of identifiable factors. Exercise judgment within defined practices and policies in
selecting methods and techniques for obtaining solutions. Act as advisor to teams/team members to meet
schedules and/or resolve technical problems. Approve/prepare Investigative and Variance reports. Revise
and write Microbiology SOPs and protocols. Represent department during client and regulatory agency
audits.
Consultant for Watson Pharmaceuticals,Inc.
Corporate Quality Assurance Specialist,
Senior
03/2011-11/2011
Duties / Responsibilities:
Route quality agreements from corporate headquarter and local facility to third parties.
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Communicate and correspond both orally and in writing with government agencies as assigned. Point of
Contact and Lead during cGMP internal and external audits as assigned.
Create change control template for quality agreement template revisions. Follow up on quality
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agreements, reviews documents, product information, deviations, investigations and other related
documents. Supports manufacturing sites by providing historical data on product related information as
needed.
Baxter Healthcare
Corporation
Manager, Compliance;
Quality Management
Laboratories
11/2009- 2/2011
Accomplishments:
Created and managed a new Compliance department to focus on investigating OOSs and OOLs
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for the entire facility. Reduced the total number of investigations by 40% from prior year.
Developed Quality Working Teams (QWTs) for each area that work together on continuous
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improvement and sharing their knowledge to better troubleshoot problems more efficiently. Established
new SOPs for investigation based on risk assessment and impact to product for OOSs and OOLs.
Developed tools and trained personnel on how to conduct internal audits, writing reports and
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presenting findings to management. During the recent FDA visit and Corporate Audit, the areas that I
was responsible for did not receive any observations.
Exceptions and GDP errors were reduced 65% from prior year based on the audits and
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suggestions that were made by the Compliance team; all based on m y action plans or improvement
charters.
Duties / Responsibilities:
Planned, directed, and coordinated the operational activities of the Compliance Department that
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support the Microbiology & Biochemistry laboratories with budget of $10 million range. Manage two (2)
Supervisors and approximately 110+ Associates within these departments.
Monitored the implementation and compliance of the requirements established by the Plant’s
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Quality System. Planned, scheduled, coordinated support and led detailed audits of facility practices to
ensure that policies and procedures complied with FDA, MHRA, MOH, Health Canada, and Corporate
Quality Policy guidelines. This included review of updated GMP regulations and current FDA and outside
of US requirements and incorporated into internal programs, where appropriate.
Performed internal audits / assessments by collecting and analyzing objective evidence regarding
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issues and risks. Ensured that audit schedules were produced and communicated in a timely fashion.
Supported and led for-cause audits, as needed. Assisted in planning and developing audit assessment
strategies and logistics. Reported weaknesses, ineffective procedures, policy exceptions and
discrepancies and recommended appropriate corrective actions. Reported findings (verbally and written)
to management.
Evaluated corrective and preventive action responses to assessment findings for adequacy,
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including root cause and timeliness. Elevated issues to management, as appropriate. Responsible for
conducting and confirming follow-up actions on Corporate, Client, Regulatory and Internal site compliance
audits. Reported extended corrective actions to management.
North American Science Associates (NAMSA)
Manager, Microbiology& Chemistry
Departments
04/2008- 09/2009
Accomplishments:
During a FDA visit and Corporate Audit, the areas that I was responsible for did not receive any
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observations. The Microbiology department was audited by corporate and customers a total of forty-five
(45) times without any observations, some suggestions were implemented after evaluating impact on the
Quality Systems as a whole.
Restructured and managed the Microbiology Department, which included laboratory design and
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establishment of SOPs and test methods to support customers (Medical Device to Biotech) with products
or samples from R & D to Commercial Production.
Improved testing effectiveness for the entire department by 35% and customer relationships. Hired
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over half of the department to fill gaps in technical knowledge and experience that better met customer
and m y expectations.
Duties / Responsibilities:
Planned, directed, and coordinated the operational activities of the Microbiology & Chemistry
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laboratories with annual sales in the $5 million range. Managed four (4) Supervisors and approximately
25-30 Associates within these departments.
Confirmed Quality Systems were being applied in the performance and documentation of
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Laboratory Studies & Production Processes.
Assured Test Methods & Production Processes met specified Protocol or SOP requirements, were
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scientifically sound and were performed error-free. Tracked, monitored, recommend and implemented
improvement activities that achieved Annual First Pass Yield Objective(s).
Participated in audits by Clients or Regulatory Bodies. Addressed observations or
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recommendations and implemented corrective/preventative actions where necessary.
Assisted the Laboratory and Production Department with the interpretation of test results and
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determination of additional steps to be taken. Performed failure investigations identifying Root Cause and
Corrective/Preventive Action. W orked with other department Managers to standardize work practices
throughout the organization. Participated in Micro Summit activities.
Met client expectations for timeliness of Laboratory Studies and Product shipments as measured
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by On-Time Percentage. Analyzed and resolved Internal and/or External delays; identifies trends.
Implemented improvement activities that achieved annual On-Time Objective(s). Worked with National
Account Managers (NAMs) to insure customer expectations were understood and met, and promoted
Microbiology services as needed.
Accomplished Financial and Business Objectives by forecasting requirements/capacity; prepared
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Annual Capital and Expense Budgets; scheduled expenditures; analyzed variances; and initiated
Corrective Actions.
Advised clients on and resolved Technical Issues. Reviewed incoming requests for technical
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appropriateness of testing that met client needs.
Mannkind
Corporation
Senior Manager,
Quality Control
06/2004 – 04/2008
Accomplishments:
Created and managed a new Microbiology Department, which included laboratory design and
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establishment of SOPs and test methods to support several departments from R & D to Commercial
Production.
Created and managed a new Sample Control Unit to handle and schedule all samples tested in
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the labs. Prepared the QC Labs for a PAI visit from FDA for a new product that was submitted to FDA for
approval.
Reduced the annual laboratory-operating budget of $1.5 million by 30%. Improved testing
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effectiveness of finished products and raw materials by 65%. Reduced outside testing costs from
$160,600 to $62,000/year through more effective use of laboratory resources, which included the transfer
of microbiology testing in-house.
Duties/Responsibilities:
Responsible for staffing, organization, operation, budget and maintenance of the Microbiology
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Laboratories in compliance with company policies, objectives and applicable regulatory agencies (FDA,
OSHA, EP and JP).
Responsible for identifying and recommending timely corrective and preventative actions to
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maintain the Manufacturing Facility in a state of compliance.
Established and maintained the Facility’s EM Program. Managed personnel qualification and
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routine monitoring. Presented quarterly trending of EM (e.g. Clean Rooms, Control Areas and Sampling
or Incoming Areas) and Water Systems data (e.g. WFI, RODI and Pure Steam), and managed the facility
qualification and validation.
Responsible for performance evaluations, positive feedback, disciplinar y actions and counseling.
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Possessed excellent people management, conflict resolution and mentoring skills to promote teamwork.
US Alpharma
Senior Manager of Quality Systems
04/1999 – 03/2004
Accomplishments:
Reorganized the Quality Laboratories in preparation for an FDA audit in relationship to the
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company being in a Consent Decree. Executed cost-cutting measures to reduce the annual laboratory-
operating budget of $2.3 million by 35%.
Improved testing effectiveness of finished products and raw materials by 40%. Reduced outside
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testing costs from $220,000 to $60,000/year through more effective use of resources, which included the
transfer of microbiology testing to a central testing site.
Duties/Responsibilities:
Managed all activities associated with the daily operations of the Quality Laboratories (Analytical
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and Microbiology).
Established a laboratory program for training and qualifying microbiologists and technicians. Trainer
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for investigation writing and trending.
Developed work practices and procedures that were in compliance with company and regulatory
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requirements. Communicated effectively across a number of disciplines. Interpreted and resolved complex
issues. Effectively reviewed and edited reports and regulatory submissions within own discipline.
Booz Allen Hamilton
Senior Consultant III
06/1997 – 03/1999
Accomplishments:
Presented recommendation based on inspections to corporate executives concerning gaps in
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Quality Systems at their manufacturing facilities abroad.
Being asked to conduct a mock inspection of other facility where they have concerns from Quality
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Systems to Validation. In a period of (8) eight months and visited over 20 facilities for 6 different
pharmaceutical companies.
Duties/Responsibilities:
Worked with several major international pharmaceutical companies in the areas of cGMP
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compliance, manufacturing quality management/initiatives for the reengineering of quality systems and
functions.
Structured a Project Management Organization for a large-scale project in the pharmaceutical arena
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using Microsoft Project, etc., for process base lining and process mapping. Provided assessment reports to
departments and corporate headquarters on the effectiveness of systems, controls, and compliance
programs.
Wyeth Pharmaceuticals
Senior Manager of Microbiology Laboratories
02/1992 – 04/1997
Accomplishments:
Selected by upper management at the facility to work with an internal third party consulting group
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that manages all releases of finished products. Learning their principles that go into decision-making when
concerns arise with exceptions for documentation and OOSs.
Representing the Quality Laboratories in preparation for responses to the third party inquires for
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finished product release.
Duties/Responsibilities:
Responsible for the management of Bioburden, Endotoxin and Sterility testing for multi-system
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product release and Stability. Supported facility qualification, validation and aseptic media fill for all product
platforms.
Established and maintained the Facility EM Program. Provided guidance for setting microbiological
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specifications and EM facility alert and action limits, as well as microbiological controls for the device and
facility that comply with current ICH, FDA, EMEA and GMP regulations.
EDUCATION:
University of Florida
Bachelor of Science Degree in Microbiology & Cell Sciences
Minors: Chemistry & Mathematics
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