John A. Shirley

**** *******, ********, ** *****

727-***-****; ad3ewt@r.postjobfree.com

OBJECTIVE:

Quality Assurance / Quality Control, Quality Inspector, Calibration Technician, Production Technician

Participate as an assistant to engineering, utilizing skills in ASQ, CQT, and cGMP’s, calibration, and quality assessment for an industry leader focused on pharmaceuticals, biotechnology and/or related manufacturing that provides challenges with measurable compensatory results.

QUALIFICATIONS

Essential Duties and Responsibilities:

Essential Duties and Responsibilities:

· Experience with FDA, CFR and cGMP

· SPC, Statistical Analyzer

· Quality Control / Standards Process

· Reliable, Model Technician

EXPERIENCE

Contract Employee, Temporary Service Company

Pyramid Consulting, Inc., 3060 Kimball Bridge Rd., Suite 200, Alpharetta, GA 30022

Calibration Technician, Baxter Health care Corporation, Largo, FL

July 2023 to November 2023

Performs calibrations and maintains the calibration schedule system to conform to facility and Client’s global requirements.

Essential Duties and Responsibilities:

Tests and calibrates measuring and indicating instruments for conformance to established government, commercial, and specification standards.

Sets up test equipment, measures accuracy of instruments used to record voltage, pressure, temperature, etc.

Adjusts instruments to meet instrument manufacturer and calibration standards.

Coordinates outside calibrations (at OEM or at approved Calibration Service Supplier), including request of quotes, opening requisitions in the approved Purchasing system, performs inspections and documentation reviews on these instruments.

Maintains calibrations scheduling database and ensures timeliness of calibrations.

Reviews and approves Calibration database records for new instruments and changes to the instrument master record. Completes calibration assessments for instrument related changes. Performs duties as assigned.

Quality Assurance Specialist, Valpak, Saint Petersburg, Florida October 2022 to April 2023

Facilitates and implements quality processes based on Lean Manufacturing principles. Collaborates in disposition of non-conforming material. Tracks and communicates quality data to other families and areas. Contributes to continual improvement activities using various problem-solving tools.

Essential Duties and Responsibilities:

Accountable for determining the disposition of non-conformances of raw materials, product components, and finished goods on a designated shift. Works directly with Operations to maintain quality standards as outlined in standard operating procedures (SOPs).

Monitors production and quality, anticipates and solves problems/non-conformances in a timely manner and identifies opportunities for improvements.

Partners with Operations leadership and support personnel to make sure that approved systems, methodology, processes are being used, preventative maintenance and other operational programs comply with published company standards, data collection and reporting, and root cause analysis activities are used to resolve quality issues.

Ensures that quality related deficiencies are adequately investigated, documented and corrected.

Maintains understanding of operations, SLA’s, SOP’s, Aris mapping, reporting as related to production and quality activities.

Participates with cells/teams and Operations leadership in continuous improvement activities and projects by providing relevant information and data for decision making to drive improvement results.

Demonstrates sound judgement and experience with product disposition and reporting analytical data.

Prepares and or assists with Form/logs Job Aids, Work Instruction and templated to achieves Valpak’s quality standards.

Provides guidance and training support on quality related topics and processes for operations.

Maintains technical knowledge as it relates to production and quality programs in a lean manufacturing environment.

Provides assistance to the quality lab on testing of all raw materials, product components and finished goods.

Accomplishes duties using safe work practices and equipment while being responsible for reporting all injuries and observed unsafe conditions. Coaches’ fellow employees on safe work practices as appropriate and contributes to the overall success of the Company’s safety program.

Performs related work and additional duties as needed or required.

Manager, Quality Assurance, Regenerative Processing Plant, LLC

Palm Harbor, Florida February 2022 to October 2022

Develop and implement Quality Assurance (QA) strategies, implement quality system regulatory procedures and initiatives in order to achieve compliance with FDA 21CFR Parts 210, 211. Maintain Quality Assurance, policies, processes, procedures, and controls ensuring that performance and quality of the products conforms to established standards and agency guidelines. Provide leadership for Quality Assurance improvements, and business process improvement initiatives.

Essential Duties and Responsibilities:

Provides dedicated QA support to projects and quality oversight of GMP operations for the manufacture of bulk drug and / or final drug product.

Primary Quality Assurance contact during any project lifecycle.

Responsible for review and approval of master documents supporting the manufacture of products.

Oversees the coordination and review of executed manufacturing documents.

Supports and / or leads on-site audits and participates in on-site technical visits.

Facilitates resolution to quality issues and interfaces with the gain concurrence, ensures that non-conformances are thoroughly investigated and documented.

Act as first responder and approval authority for quality issues and activity pursue timely, complaint closure and documentation of all events and investigations and required immediate corrective actions.

Develop standard work practices to ensure high and consistent level of quality is maintained. Provide training in standard work specifics. Support, participate in, and approve compliance critical efforts.

Lead and participate in site quality and process improvement initiatives to ensure compliance and efficiency. Manage nonconformance, investigations, corrective actions, preventive actions, deviations, and customer complaints.

Participate with peers in the formulation of overall direction, processes, systems, and talent development for the Quality Department.

Review and sign off on product and manufacturing changes for compliance with applicable regulations.

Provide technical guidance and training / mentoring to other Quality Assurance employees and cross-functional teams.

Assist with archival of Quality documents and records in accordance with federal regulations.

Use databases to track, trend, report QA activities and identify improvements.

Support regulatory (i.e., FDA) and audits / inspections of RPP.

Manage special projects as needed.

Quality Inspector, Enzymedica, Inc.

Venice, Florida March 2021 to January 2022

Essential Duties and Responsibilities:

Complied with FDA’s cGMP regulations for Dietary Supplements as defined in 21 CFR 111. Wrote and revised company Standard Operating Procedures (SOP’s).

Inspected incoming components for approval or rejection. Identified deviations and took proper steps for corrective and preventive actions (CAPA’s).

Approved/Rejected disposition of returned product.

Conducted production start-up and in-process quality inspections. Processed production batch records. Approved/Rejected finished goods. Performed label reconciliation and label control.

Maintained, monitored and organized Quality and GMP related documents, and facility programs for climate control and pest control.

Produced records utilizing GDP (good documentation practices).

Participated in third party audits and mock recalls. Adhered to all Enzymedica, Inc. policies, procedures, safety rules and regulations. Participated in Performance Improvement and safety initiatives, including job related and annual training(s), i.e., cGMP.

Technician, PGT Industries

North Venice, Florida June 2020 to January 2021

Essential Duties and Responsibilities:

Assembled components for doors and windows and performed tasks in glass operations. Tasks in assembly plant included, but not limited to: Weather Stripping, Glass/Frame Cleaning, Bead Installation, Grill Kit Installation, Muntin Application, Chop Saw, Dies, Scanning, Packaging, Banding, and Off-Loading Glass Operations included: Clave Offloading, Cart Pusher Operation, Logo to Glass Application, Offloading to Carts, Identifying Defects, and Glass Disposal. Ability to complete all tasks within required position capably and efficiently. Understood and promoted team and company culture. Consistently focused on assigned task both physically and mentally. Contributed daily to achieving team goals. Demonstrated ability and willingness to be flexible (performing alternate tasks, supported other mfg., lines). Complied with safety regulations and routinely wore PPE and ensured team members followed PPE guidelines.

Contract Employee, Temporary Service Company

Johnson Service Group, Inc., Saint Petersburg, FL February 2020 to April 2020 Quality Assurance Technician, Omnicell, Inc

Assign to work with Engineering, performing dimensional analysis on product using a Magnet-Mike.

Essential Duties and Responsibilities:

Inspection of manufactured product using calipers, micrometers, color spectrometer, and such to verify acceptance criteria.

Calibration Technician, Grand Rapids Metrology

Grand Rapids, Michigan July 2018 to February 2019

Essential Duties and Responsibilities:

Perform calibrations and adjustments in accordance with approved standard procedures. Ensure calibration standards and test equipment is in compliance. Assist in writing and updating procedures to ensure efficiency, standardization, and accuracy. Drive company vehicles to designated customer locations. Document work and create certificates in asset management software. Review all calibration documentation for completeness and accuracy. Comply with safety regulations and maintain clean and orderly work areas. Interact with customers and identify their needs to achieve satisfaction. Perform other laboratory support functions as required in an efficient manner. Follow all company procedures.

Quality Execution Technician, Leprino Foods Company Allendale, Michigan October 2016 to July 2018

Essential Duties and Responsibilities: Assists in the development and maintenance of product quality programs by collecting and testing samples, supporting production, monitoring sanitation, and training. Maintaining quality and safety standards, keeping records, maintaining equipment and supplies. Monitor the quality of the product for flavor, cut, extraneous, etc.; ensure the specifications are being met. Perform metal detector checks to ensure that the product is safe and wholesome. Monitor GMP’s in Production and Processing Areas. Swab equipment and inspect the equipment via the environmental procedures. Initiate Quality Alerts and Deviations when necessary. Calibration of Lab Equipment. Shipment of samples to Corporate Testing Lab.

Production Operator I, SPI Pharma Grand Haven, Michigan April 2015 to October 2016

Essential Duties and Responsibilities:

Accountable for all documentation and production required fulfilling the cGMP requirement for the plant. Alert the Team Leader to safety, quality, and equipment problems. Basic understanding of materials handling to prevent contamination and to comply with cGMP’s and customer requirements. Obtain in-process product samples, when necessary, using proper sampling procedures. Knowledge of scales, calibrations, and accuracy requirements, demonstrate proficiency to operate and control at least 4 different processes, and performing system cleanouts. Monitor the reliability and integrity of all equipment used in the current process. Understand the control systems used in the processes well enough to understand when process variations are occurring and how to correct them. Have a sense of urgency for addressing production, quality, and safety issues; provide basic troubleshooting for minor equipment problems. Work with Quality Department and site leadership to revise documentation (SOP’s, batch records, checklists, etc) to reflect current practices in manufacturing. Assist in the training of other operators as needed.

Calibration Technician III, Covidien (Medtronic & Covidien) Plainfield, Indiana August 2014 to March 2015

Essential Duties and Responsibilities:

Performed monthly Calibrations on Medical Devices from the Factory Service Floor, including Calibration Reference Standards. Query and evaluated data for Quality Assurance Metrics. Improved the method and time allotted to perform calibrations, through photographs of calibration set-ups, and kits of components used during calibration. Implemented 5S Organizational Concepts and Techniques throughout the Calibration Laboratory. Revised Standard Operating Procedures, and Engineering Change Orders used as protocol when performing a calibration, or for future calibrations. Researched other Outside Service Calibration laboratories for equipment requiring calibration, maintenance, or repair outside the abilities of In-house resources. Correspondence with other Medtronic & Covidien sites regarding acquisition of equipment and procedures or methods of performing calibrations.

Contract Employee, Temporary Service Company

1. First Call Temporary Services, Inc, Indianapolis, IN July 2014 to August 2014

Production Technician, 3M

Manufacturing of Ear Plugs

2. Miller Consulting Group, Inc, Indianapolis, IN May 2014 to June 2014

Manufacturing Technician, Automatic Pool Covers

Assembly, inspect, and package product orders

Production Technician, Roche Diagnostics Corporation, Indianapolis, Indiana April 2010 to May 2014

Essential Duties and Responsibilities:

Responsible for overall process monitoring, troubleshooting, and statistical process control. Certified on the operation of the CD-01, and CD-03 Coat and Dry Machine. Alerting the Production Supervisor or Process Specialist whenever the suitability of product is in question is another responsibility. Executing changes to the Coat and Dry Process during Pilot Production at the discretion of Process Scientist, Engineering and Validation. Participates in Process Improvement activities.

Senior Calibration Technician, Baxter Pharmaceutical Solutions, LLC, Bloomington, Indiana August 2007 to April 2010

Essential Duties and Responsibilities:

Follows sequence of testing from calibration procedures for instruments and equipment and ensures all tasks are performed in compliance with applicable Standard Operating Procedures. Creates and maintains equipment file for each piece of test/manufacturing equipment requiring calibration. Sets up standards and special purpose laboratory equipment to test, evaluate, and calibrate other instruments and test equipment. Applies formulas to solve problems in measurements and calibrations. Ensures all tasks are performed in compliance with applicable Standard Operating Procedures. Serves as a technical resource on metrology issues.

Quality Inspector, OMC Precision Products, a Division of Paragon Medical, Inc Indianapolis, Indiana April 2007 to July 2007

Essential Duties and Responsibilities:

Performed first-article inspections, in-process inspections, and final inspection on parts. Visual inspections on parts for blend lines, burrs, and surface finish. Identified and reported all process and product non-conformances. Communicated discrepancies to the appropriate management representative in order to ensure all products met customer specifications.

Quality Control Assistant (3yrs.); Aseptic Pharmaceutical Technician (previously: 3 yrs.) Eli Lilly & Company Indianapolis, Indiana June 2001 to January 2007

Essential Duties and Responsibilities:

Conducting finished product statistical sorts. Authorized to handle special security substances. Performed setup of aseptic connections in a class 100 sterile environment. Completed all job tasks, manipulations, calculations, and interventions according to procedures, policies, cGMP’s, and FDA regulations.

Quality Technician III, Endress + Hauser, Incorporated, Flowtec DG Greenwood, Indiana September 1998 to May 2001

Essential Duties and Responsibilities:

Evaluate products (i.e., Flanges, tri-clamps, gaskets, and hardware) using Dimensional Analysis and Metrology, (i.e., AutoCAD and CMM). Test for both First Article Inspections and Incoming Inspections. Performed Internal Audit ISO-9001 with department staff to test standards compliance, and oversaw daily operations within standard expectations. Expertise in Calibration, Gage R&R studies, and Advanced Metrology meeting FDA requirements.

EDUCATION (Degree):

Associate of Science: General Technical Studies, Magna Cum Laude, Ivy Tech State College, Indianapolis, IN, May 2004

Diploma, North Muskegon High School, North Muskegon, Michigan

EDUCATION (Completed Courses):

Courses at DeVry University in B.S.: Technical Management (winter ’05 – summer ‘06)

Courses at IUPUI in Mechanical Engineering Technology (fall ’04 – fall ’05)

Certified: American Society for Quality: Certified Quality Technician (CQT), Certified Mechanical Inspector (CMI).

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