Erika Beck Email & Phone Number

Wayne, Pa, Us

• Obtained biologics license (BLA) for Join Parachute and, through PAS, have added a growing number to the license• Oversee Change Control Department• Oversee Internal Audits• Oversee enrollment of new facilities in regulatory agencies (PPTA, ACHC, FDA, CLIA, AAB)• Manage projects for continuous improvement across the company• Authorized official for FDA correspondence• Respond to all regulatory requests, intermediary and formal (customer, FDA (483, RFI), CLIA & trade organizations)• Oversee Quality of Software (Aug 2021-Jan 2023) and equipment validations (current)

• Integral team member in the submission of first Biologics License Application with FDA

Austin, Tx, Us

• Supported centers during external audits (regulatory and customer) to ensure inspectors receive requested information promptly.• Trained new hires to the Compliance Department• Assisted Compliance Director with gap analyses to ensure updated regulatory guidance is reflected in the DMS• Drafted formal responses to MHRA• Completed multiple major process changes via change control. Developed new SOPs and reworked existing SOPs for process improvements and to address deficiencies (from inspections or internal CAPAs)• Participated in the deviation management investigation process as both a non-conformance report owner and SME reviewer

Austin, Tx, Us

Resumed many of the Validation Specialist responsibilities to fill the vacant positions temporarily. Trained the new hire and assisted their transition.

Austin, Tx, Us

• Supported centers during external audits to ensure inspectors receive requested information promptly.• Completed cross-functional tasks that were the Regulatory Affairs Manager and Compliance Specialist's duties • Updated the Compliance Department's eLMS training matrix to better suit the needs of the department and the functionality of the system• Worked with the Head of Quality to develop responses to a massive inspection effort by a customer with 173 observations

Austin, Tx, Us

• Executed multiple key document revisions for process improvements and audit responses• Facilitated multiple successful audits by the UK’s MHRA as a scribe and subject matter expert• Expanded and developed the corporate level shipping release department and its systems• Reviewed freezer validation packets for new, remodeled, repaired, and periodic re-validations of walk-in freezers at BPL plasma centers• Researched and analyzed many different data sets for Sr VP of Quality, VP of Business Development, and President for customer & regulatory notifications• Continued the role of corporate risk management coordinator: led meetings, reviewed and approved impact assessments and FMEAs, assisted in the improvement of the risk management system• Facilitated training for peers and managers as a designated trainer for both Equipment Validation and Shipping Release. • Performed quality functions within the guidelines of EudraLex Volume 4: EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, FDA cGMP 21CFR, EU GMP Guide, & IQPP Standards.

Austin, Tx, Us

• Played a key role in the overhaul of SOP 9008 CAPA Database Entry, Rev 3, held training for successful rollout within the Lookback/Deviation Department• Facilitated multiple successful audits by the UK’s MHRA as a document runner, scribe, and subject matter expert• Directly collaborated on new procedures with a consultant and former FDA Regulatory Project Manager for Blood Applications • Supported the corporate effort to centralize quality functions by writing interim data management processes for transferring a paper-based system to an electronic system for use by a geographically split department• Expanded company-wide quality report for investigation tracking to include more metrics and eliminate errors• Evaluated center-reported post-donation information and shipping errors to determine donor and product suitability• Responsible for generating Biological Product Deviation Reports (BPDRs) for the FDA and consignee lookbacks for customer notificationExpanded duties beginning June 2017:• Reviewed freezer validation packets for new, remodeled, repaired, and periodic re-validations of walk-in freezers at BPL plasma centers• Coordinated complete review of all shipments under new donor management system from November 2016 to July 2017 in less than 2 weeks• Researched and analyzed many different data sets for Sr VP of Quality and VP of Business Development for customer & regulatory notifications• Took on the role of corporate risk management coordinator: led meetings, reviewed and approved impact assessments and FMEAs

Wilmington, Nc, Us

• Managed technical staff during pharmacokinetics study conduction. • Coordinated with the research team to ensure successful study conduction.

Wilmington, Nc, Us

Rosenberg, Tx, Us

New York, Ny, Us

New York, Ny, Us

San Marcos, Tx, Us

Bs, Biochemistry

Biochemistry

High School Diploma