CHAD M. GERBICK

330-***-****

acd4hk@r.postjobfree.com

CAREER SUMMARY

Quality Manager with expertise in aseptic manufacturing, product disposition, investigations and analytical chemistry in

the world’s top pharmaceutical companies. Proven success in leading cross-functional teams for site critical

investigations and working directly with regulatory agencies and contract customers during site inspections.

Known to be a consistent, analytical decision maker and people leader who develops and empowers team members

through mentoring and performance management.

PROFESSIONAL EXPERIENCE

KELLY SERVICES INC. / JANSSEN SUPPLY CHAIN, JOHNSON & JOHNSON, Bedford, OH

Manufacturer of liposomal doxorubicin bulk solution for Doxil® (Caelyx™).

Quality Assurance Disposition / Batch Record Review 2014 – Present

Managed batch record review and product disposition under FDA Consent Decree.

- Created and implemented a new document management system to maintain control of procedures and provide

accessibility to operators for day to day functional use.

- Created and implemented a new batch record review and disposition process to facilitate successful product

certification under FDA Consent Decree.

- Created and implemented a new direct material disposition process to guide the consistent assessment of incoming API

and excipient chemicals for manufacturing use.

BOEHRINGER-INGELHEIM, BEN VENUE LABORATORIES INC., Bedford, OH.

Manufacturer of liquid and lyophilized parenteral pharmaceutical products.

Manager Product Disposition 2012 - 2013

Managed batch record review and product disposition for generic, contract and 3 rd party CMO products under FDA

Consent Decree.

- Redesigned the batch disposition comprehensive assessment to include standard review elements. This improved the

consistency of the assessment while creating more defendable accept/reject decisions.

- Improved the accuracy and efficiency of the batch record review process by moving qualified auditors to the

production floor. This increased the speed of review, improved the identification of deviations in real time and

improved the rapport between Production and Quality employees.

- Streamlined the batch record contents and compilation/review process by removing nonessential documents and

developing summary reports for incoming Microbiology and QC Chemistry results. This significantly reduced both

document review time and clerical responsibilities.

Developed and lead the issue resolution process for 3rd party batch record certification under FDA Consent Decree.

-

This created standard expectations for cross-functional work groups, leading to more efficient meetings, faster product

disposition and more predictable make-to-release timelines.

- Acted as the primary Quality interface for contract customers regarding deviation events, product disposition process

and on-site visits.

- Served as Quality Management representative for regulatory agencies and contract customers during on site audits and

inspections.

Supervisor Quality Assurance 2011 - 2012

Managed the direct Quality oversight of Manufacturing Operations, including aseptic filling and sealing activities, and

provided final approval of all associated deviations, investigations, CAPAs, changes and protocols.

- Directed the successful startup of the South Facility following an extended shutdown period, allowing the return to

manufacture of products on the FDA’s drug shortage list.

- Lead the site critical investigation for particles found in Line 112 initial water runs. This resulted in the initiation of an

ongoing particle monitoring process as part of the Quality System.

Page 1 of 3

- Lead the site critical investigation for moisture discovered in the wall of a gowning anteroom. This resulted in

improvements to the preventive maintenance for all water sources throughout the facility and facilitated a return to

production.

- Managed the 24 hour Quality oversight of all production activities in the South Facility. This resulted in real time

decision making and allowed scheduled manufacturing to remain on target.

- Lead the ICH Q7A facility inspection and Quality System audit of several international API suppliers (India).

- Served as Quality Management representative for regulatory agencies and contract customers during on site audits and

inspections.

Supervisor Quality Systems 2007 - 2011

Managed the execution and final approval of manufacturing and laboratory related deviations, investigations, CAPAs,

changes and protocols.

- Lead the QC Chemistry backlog reduction project, resulting in a 60% reduction in open investigations. This

created a more streamlined and rapid response for deviation and investigations, enabling all QC deviations to close

within 30 days.

- Lead training and served as primary reference for the TrackWise quality management software. This enabled

users across the site to consistently enter data, resulting in more effective historical queries for trending.

- Redesigned the TrackWise investigation and protocol workflows. This resulted in logical TrackWise fields that

matched the SOP requirements and provided improved report formatting for regulatory agency and contract customer

audits.

- Provided Quality oversight for the Stability program as a participating member of the Stability Review

Committee.

- Provided Quality oversight for QC Chemistry as a participating member of the CAPA Review Board.

- Completed Lean Manufacturing, Six Sigma Green Belt training.

- Lead ICH Q7A facility inspections and Quality System audits of international API suppliers (China, Spain,

Taiwan).

- Served as Quality Management representative for regulatory agencies and contract customers during on site audits

and inspections.

Supervisor Quality Control 2000 - 2007

Managed the analytical chemistry testing of lyophilized and liquid parenteral finished goods, in-process samples, raw

materials, and shelf life studies.

- Reduced the average cycle time of sample distribution from 5 days to 2 days. This allowed more immediate

testing initiation and reduced make-to-release timelines.

- Improved on time completion of contract product testing from 80% to 100%. This resulted in improved client

satisfaction and allowed more flexible instrument scheduling.

- Lead the Corrective Action Subcommittee for the BVL Quality Improvement Team. This created improved

awareness of the impact of batch record errors and the development of a tracking and reporting system.

- Managed the Stability program for generic and contract customer products.

- Served as Quality Management representative for regulatory agencies and contract customers during on site

laboratory audits.

- Lead OOS laboratory investigations and performed method/instrument troubleshooting.

- Performed final approval of finished good COAs, raw material COAs, in process sample results and Stability

summary reports.

Chemist II Quality Control 1997 - 2000

Performed chemical analysis (USP/EP/JP) in a cGMP/GLP environment using instrumentation including HPLC, GC,

UV/VIS, IR, TGA, FTIR, KF, pH and AA.

Sterile Room Worker 1996 - 1997

Performed cGMP production activities in a “Class 100” clean room including freeze dryer loading, filling and sealing.

Performed final inspection, labeling and packaging as a material handler and qualified inspector.

EDUCATION

- B.S. Biology and Pre-Medicine, Kent State University, Kent, OH

- Certified Quality Auditor (CQA), American Society for Quality (ASQ)

Page 2 of 3

Page 3 of 3

Contact this candidate