Document Control Documentation Specialist

• Beatrice Mincarelli

* ******** ******, ***** *********, NJ 0802

Home 732-***-**** Cell phone 732-***-****

E-mail address: *******@*******.***

Professional Experience:

Strive Pharmaceuticals Inc. East Brunswick, NJ 08816 09/29/2022 to present

• Complaints

• Quality Assurance Documentation Specialist

Experic

Quality Assurance Specialist I Cranbury NJ 088512 01/14/2020 to 02/25/2022

• Assist in daily administration activities associated with Quality System areas such as

Training, Document Control, CAPAS, Deviation/Nonconformances, Product Complaints,

Change Control, Supplier Qualification & Audit Program, Internal and External Audits

and Management Review.

• Performs and maintains day to day Document control function within the paper based

QMS at Experic, Manages and owns the Experic Controlled Document Master

List/Master Index

• Maintains original and scanned copies of all controlled documents and deliverables in

the Experic Document Control Room, and other locations, as Directed by Quality

Management.

• Coordinate and support training program to ensure compliance as well as escalation of

issues to the Quality Management.

• Work with cross-functional organization to review and maintain controlled documents

(i.e., SOPs, Policies, Work Instructions etc.) to ensure adequacy of content, compliance

to applicable GMP regulations/industry best practice standards and consistency in

format.

• Communicate Quality issues to Quality Management and collaborate with various

technical departments to drive remediation initiatives.

• Perform all Quality Department administrative functions as required.

Tyler Distribution Center

Quality Compliance Specialist, Cranbury,NJ 088512 02/19/2019 to 07/16/2019

• Coordinate the revision, review, and approval of Standard Operating Procedures

(SOPs), Work Instructions, and controlled forms and quizzes, as necessary

• Prepares for internal and external audits

• Participate in mock recalls

• Report food safety and quality problems to Plant Management

• Monitor fellow employees for adherence to GMP’s

• Review and complete relevant documents for customer-specific compliance requests

• Upkeep of training records

Draka Downhole Technology, Bridgewater, NJ 08807 06/13/2016 to 02/16/2019

Technical Support Specialist

• Manage document control process through a common shared drive.

• Track standard operating procedures (SOPs), forms and other regulated documents to

ensure timely and accurate review and content.

• Recommend create implement, and update SOP’s, as necessary to reflect current

practices and support compliance.

• Support the maintenance of Quality Management System(QMS)

• Updating and maintaining weekly reports for CCRs (Customer Complaint Requests),

CARs (Corrective Action Requests), NCM (Non-Conformance Reports) and DMRs

(Deviation Material Reports) Vendors.

• Maintaining Training Forms in Training Manager 2012-Enterprise Edition

• Assist in developing and maintain a comprehensive filling system and database for all

quality documents, such as Quality Manuals, Procedures, Work Instructions,

Certifications and Inspection Data Sheets.

• Provide support to the QA team during regulatory agency inspections or third party

audits by participating in inspection preparation and assisting the inspection strategy

room.

• Prepared quality document packages for customers.

Vention Medical, 6 Century Road, South Plainfield, NJ 07080 06/2014 to 05/2016

Document Control Specialist (Quality)

• Reviewed and approved production batch records for release by ensuring work order,

production process and finished good inspection sheets, in-house labels and quantities

are accurately documented and in compliance with company SOP’s and other guidance

documents.

• Ensure closure of all deviation reports and investigations are completed prior to release

of finished product.

• Review and approve documents in Master Control System and interact with other

responsible parties so documents are approved in a timely manner.

• Perform internal audits for documentation system, consisting of (SOP, Process

Specification, Work Instruction, Forms) and binder updates for Validations, Sterilization

Process and Supplier Quality audits.

• Generate purchase requisitions and tracking PO’s for Single Source Molding Tooling

group for product development projects using QAD system.

• Creating Part Number, BOM and additional documentation for newly developed Molding

parts transferred from Product Development to Manufacturing.

Musculoskeletal Transplant Foundation, Edison, NJ 02/2002 to 01/2014

Quality Engineering Associate

• Assisted Quality Assurance, Research & Development and Regulatory with the

implementation of Quality System and Regulatory requirements as they relate to

validation activities in a highly (FDA) regulated manufacturing environment for both

Human Cellular Tissues/Products (HCT/P’s) -&- Medical Devices.

• Implemented/Supported and Written Validation Protocols and Reports with regards to:

Installation Qualification (IQ); Operational Qualification (OQ) and Performance

Qualification (PQ) for manufacturing processes and equipment.

• Followed and ensured compliance with all applicable GMP’s, CFR {& other} Federal

statutes, ISO and industry-wide rules and regulations and internal change management

procedures related quality parameters in the Human tissue-banking field.

• Implemented/Supported Design of Experiments, Engineering Studies, Stability Studies,

Water System, lyophilization and other clean room validations and process improvement

projects.

• Performed shipping validations according to AST D4169 “Standard Practice for

Perfomance Testing of Shipping Containers and Systems” and ISTA 7D “Thermal

Controlled Transport Packaging for Parcel Delivery System Shipment”.

• Performed visual inspection on stability studies for product, packaging and raw

materials.

• Performed analysis of data and report results to quality engineering management.

• Work cross-functionally with Manufacturing, Purchasing, R&D and Vendors.

• Coordinated special project testing with outside consultants, vendors or customer as

needed.

Quality Assurance Analyst 11/2002 to 10/2004

• Ensure that the documents reviewed for the release of tissue and devices are performed

according to the specifications of MTF and in compliance with all regulatory bodies.

Interacted with all departments of MTF pertaining to the quality system, production

rework/reject quantities, and other specified data.

• Interacted with all departments to organize, review and analyze all data pertaining to the

release of tissue or devices for compliance with MTF Standard Operating Procedures,

MTF product specifications and appropriate regulatory agencies.

• Reviews tissue processing records in accordance with current SOP’s.

• Reviewed recorded tissue and device measurements and other release criteria in

accordance with current finished goods specification.

• Reviewed the packaging and labeling records in accordance with current finished goods

specifications.

• Assured deviations or non-conformances have been resolved.

• Investigated discrepancies pertaining to the release of tissue/devices.

• Responsible for reporting summarized data to management for review and action,

including trend analysis.

Quality Control Laboratory Technician 02/2002 to 11/2002

• Performed general chemical and physical testing on all tissue forms, penetrometry of

matrixes materials: pH of matrixes materials, incubations of biological indicators used for

autoclave sterilization, total organic carbon (TOC) of the purified water system, package

seal strength integrity of finished good packaging, preparation of sterile filtered solutions,

and chemical concentration determinations.

• Performed record keeping for all test analysis in compliance with GLP guidelines.

• Cleaned and packaged materials and supplies for autoclaving and performed other

routine laboratory maintenance. Work with toxic and flammable materials.

Johnson & Johnson Company-Cordis, Inc., Warren, NJ 03/1996 to 12/2001

Senior Developmental Laboratory Technician

• Performed routine testing to evaluate prototype designs for Cardiovascular and

Endovascular Medical Devices.

• Trained associates in test methods and procedures pertaining to the evaluation of

prototype designs.

• Support Design Engineers in the writing and execution of protocols. Collected and

organized data pertaining to product evaluation.

Integra Life Sciences Corp., Plainsboro, NJ 08/1992 to 03/1996

Senior Laboratory Technician

• Performed physical and analytical testing on collagen material processed at different

stages as a Medical Device. Prepared solutions and reagents for test analysis.

• Performed LAL testing on clean water systems and collagen products.

• Performed inspections of incoming raw material, including packaging components and

chemical materials.

• Knowledge of DSC, optical comparator, measuring equipments (vernier, micrometer,

scales and digimatic) and spectrophotometer.

• Assisted in the developmental writing or revision of SOP’s and test methods.

Whitehall Robins Healthcare, Hammonton, NJ 04/1990 to 08/1992

R & D Stability Technician

• Evaluated OTC products using physical testing methods to determine torque, avg.

weight, thickness diameter, friability, disintegration, appearance, taste, odor, hairline

cracks, and pH, viscosity and package parameters.

• Assisted Scientist in the packaging of existing experimental OTC products used in

clinical trials and stability testing.

• Maintained Stability Chambers-monitoring temperature and relative humidity; ensure

calibration of equipment and instruments.

Wampole Diagnostic, East Windsor, NJ 10/1982 to 4/1990

Laboratory Technician

• Performed immunoassays and quantitative laboratory test. Performed physical testing:

pH, sodium azide, and thimerosal, micro testing.

• Assisted with investigational studies and new product development.

• Conducted routine testing of raw materials, pre-shipment specimens, surveillance and

Cap Surveys.

Skills

Quality: GMP, GLP, FDA, AATB, deviations, Non Conformance Reports (NCR), IQ/OQ/PQ.

Technical: Microsoft Word, Excel and Master Control

Education

Middlesex County College, Edison, NJ

Associate in Applied Science (A.A.S) Degree

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