Quality Assurance Manager

Erika Balazova

***** **. **** **.

New Freedom, PA 17349

Cell: 717-***-****

Email: ********.*****@*****.***

CAREER SUMMARY:

- Strong quality assurance background - seven (7) years of experience in

FDA regulated QA departments of major pharmaceutical and consumer

companies

- Over four (4) years of management experience - up to twelve (12)

reports

- Strong scientific/laboratory background

- External manufacturing / Third party manufacturing experience

COMPLIANCE:

- FDA, MHRA, TMOH regulated and audited roles (Consent Decree

experience)

- ICH Q7

- ISO 9000/9001 and more

- PCPC

- EPA regulations related to water/waste water management.

- USDA

QUALITY SYSTEM ELEMENTS:

- Investigations and CAPA

- Management controls

- Change controls

- DCM - Document Control Management

- Training

- Validations

- Supplier quality

- Product disposition

- Laboratory operations

- Audit and inspections

- APR - Annual product review

ANALYTICAL, RESEARCHING AND LABORATORIAL SKILLS:

- R&D Method design and validations

- USP 35 NF 30

- cGMP

- GLP, GDP

- IQ, OQ, PQ

- Risk assessments

- QRM - Quality Risk Management

- Environmental testing/monitoring

- Standard Water Methods

- Budget management

- Project management

- Technical writing

MANUFACTURING SKILLS:

- DI, RO, USP purified water system management

- Environmental monitoring and assessments

- Cleaning and sanitization validations

- New product validations

- Method validations

- Technical writing

- NC deviation investigations

- SOP development and training

EDUCATION:

- Masters degree- Biology and Environmental science, Comenius

University, Bratislava, Slovakia

- Masters degree- Environmental biology, Comenius University,

Bratislava, Slovakia

EMPLOYMENT:

Johnson and Johnson - McNeil Pharmaceuticals (OTC Solid Oral Dose)

Start: 2012 End: Current

Job Title: QC/Microbiology Laboratory Manager /Consent Decree process owner

for R&D integrations and laboratory operations

Responsibilities: Manage the QC Microbiology and R&D Microbiology testing

laboratory. Establish operating policies, procedures to ensure testing, and

evaluation activities meet all operational, environmental, safety and

security requirements.

Provide and manage cGMP and safety training to the QC Micro staff.

Provide information regarding Quality Control systems and data to internal

or external regulatory personnel during inspections or inquiries.

Develop and implement procedural guidelines within the Quality Control

Microbiology laboratory in conjunction with Central Quality Assurance and

other plant sites.

Represent the department internally and externally in matters relating to

the Microbiology Laboratory, cGMPs and general quality.

Establish/monitor overall objectives, personal develops goals, plans and

assigns work based on priorities. Develops work performance matrix and

standards.

Ensure integration of the Consent Decree multidisciplinary work-plan

projects into plant and laboratory operations.

Consult with FDA as well as the third party oversight (QUANTIC) on the

Quality System Elements integrations.

C-Care Llc. (Third party manufacturer for Procter and Gamble Company - OTC

Liquids, OTC Topical)

Start: 2010 End: 2012

Job Title: QA Manager/Laboratory Manager

Responsibilities: Assure Microbiology standards are met in manufacturing

facility producing and filling topical, OTC and personal care products

according to cGMP, cGLP and plant SOPs.

Work with engineering and other quality departments to assure sterile

equipment design, develop cleaning and sanitization procedures for

equipment and perform validation of those procedures.

Work with Customer/Technical Services on micro-sensitive pilot evaluations

& testing.

Conduct routine facility audits, frequent monitoring of facility water, and

random sampling of production equipment, tools and vessels.

Conduct all microbiology related out of specification investigations.

Procter and Gamble Company (Personal care, OTC Topical)

Start: 2007 End: 2010

Job Title: QA team member/Microbiologist

Responsibilities: Ensure quality, cost and schedules are met in the

operation of Microbiology laboratory.

Ensure compliance with cGMP, SLP and SOP in manufacturing process. Sustain

constant improvement to reduce failure, defect rates and variability.

Maintain proper documentation and statistical results to verify that

quality concepts are applied in all phases of the manufacturing process.

Conduct routine quality assurance checks, calibrate lab equipment and

assist in research and testing methods. Review calibration processes for

diagnostic equipment to ensure tools are within quality standard

specifications.

Collect samples for environmental testing of air and water and complete

variety of testing to ensure proper quality of laboratory and plant

environment.

Employer: Comenius University in Bratislava, Slovakia

Start: 2000 End: 2002

Job Title: Laboratory assistant/Professors aid

Responsibilities: Assist professors in Microbiology Laboratory with course

preparations. Assist in superintending biology department. Assist during

multiple research projects. Assist in projects involving proteins

separation from plant tissues and protein identification.

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