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15+ years of experience in Pharmaceutical and Medical Device business.

Location:
Highland Park, IL, 60035
Posted:
April 23, 2020

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Resume:

Miroslawa Zlupko

Summary:

Over **+ years of experience as Documentation Specialist in Pharmaceutical Industries and 10+ years of experience as Quality Assurance Specialist in Medical Device Industries.

Experienced in writing new and update existing procedures according to internal standards on proper methods for writing SOPs as well as according to other pertaining SOPs and documents, and standards such as cGxP.

Experienced in Reviewing and tracking of documents and also administration of departmental control documents (SOPs, Policies, WIs).

Responsible for reviewing and approving of documents in Documentum.

Extensive experience in Medical Device labeling: compliance with customer and regulatory requirements, design, accuracy, traceability, databases, printing and other.

Experienced in using Web based Documentum on daily bases to write Change Notices, and route for Review and approval to required parties.

Responsible for reviewing and reconciliation of formulation records to insure cGMP compliance.

Experienced in utilizing SharePoint to forward and track documents.

Experience in medical device and pharmaceutical products manufacturing in Quality Assurance, Compliance, Regulatory and Validation. ISO Certification and FDA compliance audits readiness and assistance. FDA Regulations

Advanced skills in Word, Excel, and Web based Documentum and SharePoint.

Advanced problem-solving skills including conflict resolution and teamwork

Education:

Northwestern University, Evanston, IL 2016

Bachelor of Science in General Studies with major in Organizational Behavior

Wroclaw University of Science and Technology, Wroclaw, Poland

Earned approximately 100 credit hours in course work towards bachelor’s degree in Environmental Engineering.

Certification:

William Rainey Harper College, Palatine, IL

Certificate-Web Development

Technical Skills:

MS Office: Microsoft Word, Excel, Power Point, and Outlook

Document & Data Management: Web based Documentum, TrackWise, Workday, LIMS, SharePoint, SAP

Web Development: XHTML, JavaScript, CSS, Dreamweaver,

Statistics: SPSS, Google Analytics

Other: Visio, Adobe Reader, Photoshop

Professional Experience:

Astellas Pharma, Northbrook, IL (contract with ProKatchers, LLC) Mar 2019 - Jan 2020

CRQA ADMS Quality Documents Control Authors Resource

Assure compliance of new and revised documents with applicable procedures and CRQA document lifecycle requirements. Create and review QDs: Policies, Standard Operating Procedures, Work in Progress, and other documents, analyze changes, conduct impact assessments, write change requests, redline QDs and discuss changes with SMEs. Verify proper training time, organizational location, and submissions of various forms. Route for approval of new, revised, and obsoleted QDs and overview of document workflow process to ensure the timely completion.

Fresenius Kabi, USA, Melrose Park, IL Dec 2009 - Feb 2019

Documentation Specialist/Operations Project Coordinator

Production metrics – collection, tabulation and trending.

Review and reconciliation of formulation records to insure cGMP compliance and ISO standards.

Review and administration of departmental control documents (SOPs, Policies, WIs).

Experienced in using Web based Documentum on daily bases to write Change Notices, and route for Review and approval to required parties.

Experienced in writing new and update existing procedures according to internal standards on proper methods for writing SOPs as well as according to other pertaining SOPs and documents, and standards such as cGxP.

Route for review and approval of documents in Documentum.

Interdepartmental collaboration utilizing SharePoint to forward and track documents.

Reviewing and tracking of documents in SharePoint.

Support of event investigations and CAPA.

Storage and update of compounding forms and logbooks.

Formulation calculations and IPC LIMS data entries.

Honeywell Uop, Des Plaines, IL Apr 2006 - Mar 2009

Engineering Technician

Electronic submissions of project specifications to customers.

Oversight for consistency of engineering specifications.

Creation of ZYQAD database workspaces.

Set up of project critical deadlines in SAP.

Abbott Labs, Abbott Park, IL Apr 2003 – Dec. 2004

Engineer II (Aug 2004 – Dec 2004)

Contracted to create summary reports of red-lined validation protocols for second signature.

Document Specialist (Apr 2003 – Apr 2004)

Supported execution of re-validation and re-qualification of utility systems and facilities.

Improved Web based Validation Library and Equipment Database.

Courtesy Corporation, Buffalo Grove, IL (Medical Devices) Oct 1986 - Jul 2002

Quality Systems Auditor and Labeling Supervisor (Apr 1998 - Jul 2002)

Managed labeling database, specifications, and procedures.

Managed three employees.

Established production controls allowing for up to 3% increase in sales.

Conducted internal ISO Quality System audits and assisted ISO representatives performing Quality system audits.

Quality Assurance Specialist (Apr 1986 – Apr 1998)

Batch records reconciliation, cGMP review and disposition.

Wrote new product specifications based on customer and internal requirements.

Wrote Procedures and work instructions for QC and QA departments.

Developed modifications of batch release process improving KPIs by 10%.

Product complaint investigations, root cause analysis, and response to customer.

Analyzed process to continually minimize errors and non-conformance.

Provided support to customers’ engineers during new product development validation runs.

Awards:

ALAMO Learning Systems - Internal ISO Quality Systems Auditor Award (ISO) - 2002



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