Regulatory Affairs

STEVEN PAVLIK

Murrieta, CA ***** • acy28s@r.postjobfree.com • 951-***-****

~ REGULATORY AFFAIRS ~

Ambitious, motivated professional with vast experience in regulatory affairs and quality control. Exhibit strong skills in communication, collaboration, and ensuring compliance. Experienced in internal and external audits, developing policies and procedures, and product testing. Demonstrated professional with an eye for detail and ability to manage and prioritize multiple projects. Solid communicator with a history of interfacing with FDA representatives, staff, and production managers, while maintaining employee proficiency. Proven expertise in:

• FDA Complaint Management

• Employee Training/Coaching

• Quality Metrics

• Audits • Communication Skills

• Collaboration

• Specification Management

• Regulatory Requirements

EDUCATION AND CERTIFICATION

Bachelor of Science in Microbiology

University of Wisconsin – Milwaukee, WI

RAC Certification in progress

Dual Certificate in Medical Devices and Pharmaceuticals, Regulatory Affairs Professional Society

7 remaining courses – Current Course – “Regulation of Dietary Supplements and NHPs” Outlines 21CFR part 111 including FDA and FTC Labeling/Advertising Claims

PROFESSIONAL EXPERIENCE

AIDAREX PHARMACEUTICALS, LLC – Corona, CA

Compliance and Regulatory Affairs Manager, 2016 to Present

Maintain and overhaul Quality System, and ensure employee expertise for Compliance Department.

Ensure regulatory compliance for all activities and guide others in the policies. Report to Board Members quarterly, review all quality control activities, and implement GDP requirements to improve accuracy and reduce redundancies. Track/trend customer complaints, recall progress, controlled substance usage, environmental data, and non-conformities for board reports. Collaborate with production managers to launch training program, including compliance orientation and job specific cGMP review for 5 managers and 18 production employees, with an emphasis on the “Why’s” as wells as the “How’s” of cGMP’s. Attend external audits by VAWD, FDA, DEA, and state boards of pharmacy; audit federal regulations 21 CFR 210, 211, and 1300; audit current and upcoming DSCSA requirements.

Key Contributions:

Performed 5 recalls; directly communicated with FDA representatives throughout recall life.

Led monthly meetings for all employees with the goal of maintaining inspection readiness of each department; emphasizing the ability to explain what was happening in each step of our processes.

Resolved FDA Form 483 received a month after beginning employment.

Retooled CAPA system to include tracking and risk based event analysis; goal to reduce future events through process improvement.

Enhanced employee performance through direct task specific coaching as well as instilling confidence in employees showing engagement and improvement.

STERIS ADVANCED STERILIZATION TECHNOLOGIES – Temecula, CA

Quality Services and Regulatory Compliance Analyst, 2015 to 2016

Ensured all processes performed followed customer specifications and protocols based on ISO-13485 and FDA 21 CFR 820.

Tracked facility metrics, including customer complaints, CAPA activities, and product damage non-conformities. Attended/assisted with regulatory and customer audits. Updated hazard communication materials and assisted with keeping the master calibration schedule.

Key Contributions:

Executed quality system internal audits every other month.

EMD MILLIPORE – Temecula, CA

Environment, Health, and Safety Tech Consultant II, 2014 to 2015

Contractor for conducting data mining on biologics product line and updating global harmonized system (GHS) standards and OSHA hazcom 2012 (CFR 29 & 49) standards.

Attended 29 CFR, GHS (M) SDS preparation, and IATA/DOT/IMDG transportation training. Approved new product launches. Obtained relevant hazard classification data for new products and 12K legacy product formulations. Trained on (M)SDS authoring and proficient at determining product formulations.

Key Contribution:

Acted as EMD Millipore representative while communicating with vendors.

UW-MILWAUKEE BIOLOGY DEPARTMENT – Milwaukee, WI

Research Assistant, 2013

SURF grant recipient; performed Psedumonas Aeruginosa research under Dr. Sonia Bardy.

Executed experiments, developed genetic constructs for experiments, maintained cultures, presented data to lab members, made media, and sanitized lab equipment and area. Reported for a portion of the chemosensory system controlling type IV pili. Utilized various molecular genetic and microbiological techniques, such as PCR, gel electrophoresis, and molecular cloning.

PROFESSIONAL ASSOCIATIONS

Regulatory Affairs Professional Society Member, 5/2016-Present

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