Work Preference
Overview
Work History
Timeline
Generic
Amy M. Bayer

Amy M. Bayer

Document Management Professional
Ballston Lake,NY

Work Preference

Desired Job Title

FACILITY RECORDS COORDINATORDocument Control Supervisor, Quality AssuranceDocument Control Coordinator, Quality AssuranceRegulatory Assistant, Regulatory Affairs

Work Type

Full Time

Location Preference

RemoteHybrid
Location: Ballston Lake, NY
Open to relocation: Yes

Salary Range

65000/yr - 200000/yr

Important To Me

Work-life balanceCompany CultureFlexible work hoursHealthcare benefitsWork from home optionPaid time offPaid sick leave401k matchStock Options / Equity / Profit Sharing4-day work weekTeam Building / Company RetreatsCareer advancement

Overview

33
33
years of professional experience

Work History

FACILITY RECORDS COORDINATOR

NY-CREATES
Albany, NY
01.2022 - Current
  • Support Facility Operations Group (FOG) and Facilities Engineering Group (FEG) by maintaining current files, documents, records, reports and manuals for facility related systems and equipment.
  • Record documents such as equipment drawings, operation manuals, preventative maintenance records, etc. shall be readily available.
  • Provide departmental support by maintaining leave calendars, new employee onboarding and other administrative duties as assigned.
  • Aid in organizing all documentation and records from previous projects by performing necessary clerical work, which includes sorting, data entry, filing, binding, copying, scanning and miscellaneous support as requested.
  • Semiconductor Manufacturing

Document Control Supervisor, Quality Assurance

AKORN PHARMACEUTICALS
Amityville, NY
01.2021 - 01.2022
  • Supervise, coordinate, and oversee the Site Document Control program for manufacturing operations with respect to issuance and control of Master Batch records and other controlled documents.
  • Ensure that GMP documents are appropriately stored and maintained in accordance with the approved site document retention policies.
  • Coordinate and run back-room support functions during audits and regulatory inspections.
  • Evaluate personnel requirements of the Document Control Group.
  • Generate monthly metrics related to Document Changes for presentation monthly to the Technical Review Board (TRB).
  • Directly responsible for performance reviews, goal setting, and personnel development plans.
  • Provide regulatory performance feedback (praise and developmental) to the QA Documentation Systems team.
  • Assist in recruiting, interviewing and hiring qualified employees to fill open positions.
  • Address personnel issues with suggestions for resolution.
  • Joined Safety Committee in August 2022.
  • An American generic pharmaceuticals manufacturer (formerly Hi-Tech Pharmacal, Inc.).

Document Control Coordinator, Quality Assurance

AKORN PHARMACEUTICALS
Amityville, NY
01.2014 - 01.2021
  • Govern processing and control of quality documents and records in adherence to company approved procedures.
  • Process/execute all phases of change controls (from initial approval to final closeout) and continually update/edit documentation in change controls; instrumental contributor in weekly change control meetings.
  • Audit quality records for completeness, accuracy, and compliance with appropriate SOPs; facilitate internal Corporate/FDA inspections.
  • Maintain all company documents (hard copy and electronic) and retrieve documents when needed (FDA and/or corporate inspections, interdepartmental requests); maintain documentation templates and oversee/execute handling, scanning, copying, indexing, data entry, filing, and achieving official records.
  • Submit documents following approval (specifications, SOPs, batch records); conceptualized, developed, implemented, and continually maintain spreadsheet designed to track filed batch records.
  • Catalog all documents into Iron Mountain Internet software.
  • Organize/initiate supply orders for Document Control and intermittently perform other duties and special projects per request by Document Control Manager and/or QA Director.
  • An American generic pharmaceuticals manufacturer (formerly Hi-Tech Pharmacal, Inc.).

Regulatory Assistant, Regulatory Affairs

LACHMAN CONSULTANT SERVICES, INC.
Westbury, NY
01.2010 - 01.2014
  • Provided all aspects of administrative support to the Regulatory Affairs Department centralized on governing compliance with applicable US and international regulations required for day-to-day business operations.
  • Produced a broad range of electronic PDF documents for regulatory submissions; finalized paper submissions for regulatory applications.
  • Provided publishing services for Regulatory submissions in correspondence to eCTD, as well as numerous other variations of electronic submissions and document publishing.
  • Developed electronic Structure Product Labeling (SPL) utilizing HL7 SPL-Drug Listing v1.04 online software.
  • Maintained active and superseded application files (both PDF documents and paper).
  • A consultation firm providing expert compliance, regulatory affairs, and technical services to clients on a global scale.

Timeline

FACILITY RECORDS COORDINATOR

NY-CREATES
01.2022 - Current

Document Control Supervisor, Quality Assurance

AKORN PHARMACEUTICALS
01.2021 - 01.2022

Document Control Coordinator, Quality Assurance

AKORN PHARMACEUTICALS
01.2014 - 01.2021

Regulatory Assistant, Regulatory Affairs

LACHMAN CONSULTANT SERVICES, INC.
01.2010 - 01.2014
Amy M. BayerDocument Management Professional