Quality Control Supervisor

J OHN B ERES 856-***-**** ****.*****@*****.*** Springfield, PA 19064

Senior level professional with a background of more than nine years in microbiology, quality control, and

environmental monitoring. Leverage team leadership and supervisory experience, coordinating department operations

and activities, introducing improvements and changes, and engaging staff to ensure on time completion and accuracy.

Apply knowledge/experience with manufacturing, laboratory, and documentation best practices to reach and sustain

regulatory compliance. Excel at resolving issues and interacting with diverse groups ranging from management to

clients to address changing needs/demands. Core strengths include:

Microbiological Testing Sampling Data Analysis & Reporting Test Design & Implementation Validation

cGMPs cGLPs GDPs SOPs Regulatory Requirements: FDA, USP, ISO, EU Microsoft Office Suite

PROFESSIONAL OVERVIEW

Senior Supervisor – Quality Control Environmental Monitoring (QCEM) UXI APPTEC: 2008 2013

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Headed environmental monitoring department, including employee scheduling, daily activities, equipment needs, and

supply ordering; oversaw four person team while operating under strict budgetary confinements. Ensured department

wide compliance with EU, FDA, USP, and ISO regulations. Conducted environmental monitoring and microbiological

testing. Communicated with existing and potential clients to address questions and supply data. Led and/or handled

the writing and updating of SOPs, BRs, CofAs, and final reports.

Introduced additional sampling activities, such as non viable monitoring, as well as increased the frequency of

monitoring for inactive suites to ensure regulatory compliance and address clients’ demands.

Designed and instituted new microbiological tests, including a bacterial cell banking testing program to test for

identity, purity, antibiotic resistance, and bacteriophage testing.

Supervisor – QCEM [2006 2008] PPTEC – ACQUIRED BY WUX : 2004 2008

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Managed daily operations for environmental monitoring program, leading a team of up to seven personnel while

performing individual environmental monitoring and microbiological testing duties. Handled employee scheduling,

supply ordering, and equipment maintenance. Interfaced with departments and managers to coordinate activities,

provide requested data, and report action limit excursions. Analyzed collected data to identify and communicate

emerging trends. Wrote and/or revised SOPs.

- Maintained department’s position as a reliable support organization for all areas, ensuring completion of daily

assignments on time and with zero interruptions to business activities.

- Contributed to temporarily scaling down the number of suites during integration with WuXi while maintaining

continuity of critical environmental monitoring areas to ensure compliance.

Senior Microbiologist – QCEM [2006]; Microbiologist I – QCEM [2004 2006]

Conducted environmental monitoring, including contact plate sampling, settle plate sampling, RCS sampling, non

viable sampling (APC, MetOne), swab testing, personnel monitoring, sterile gown certifications, WFI/RODI/

Nanopure sampling, gas sampling (Mattson Garvin, Drager, Identity), and use of biological indicators. Incubated and

read all QCEM samples. Completed microbiology testing, including sterility/growth promotion of media and submitted

samples, bacterial identification via APIs, gram staining, and membrane filtration.

- Held key role in establishing, validating, and launching environmental monitoring program for new, controlled

manufacturing site in Philadelphia with 20+ suites. Highlights include:

o Oversaw daily QCEM operations, serving as an interim team lead and department liaison for

management while supervisory position was vacant; promoted to supervisory position.

o Enabled on time program validation for on schedule manufacturing start despite challenges of rapidly

growing department, new equipment knowledge restrictions, and documentation issues.

o Contributed to completing cleaning validation for the program.

EDUCATION Bachelor of Science in Biology, Widener University

Widener University Honors Program – Certificate in Honors in General Education

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