Sophia Knight

*** ***** **** **

Woodbridge, NJ *7095

908-***-****

adunc6@r.postjobfree.com

EXPERIENCE:

Erytech Pharma Princeton, NJ 6/19- Present

Quality Assurance Specialist

In support of Erytech Manufacturing schedule, provide Quality Assurance Operations guidance and oversight on operational processes. This includes supporting Erytech Quality Management system and reviewing executed GMP documentation.

The main responsibilities of the role.

- Support real-time review of out of specification results

- Support real-time review of deviations and non-conformances

- Support Batch Record Issuance Verification

- Manufacturing Batch Record Review

- Clinical Product Disposition

- Support Quality Management Systems (QMS) with QA review on; Deviation, CAPAs, Change Controls, Customer Complaints and Self-Inspections as needed

- Support site initiatives for Inspection Readiness

- Support site initiatives for Inspection Readiness

- Support Site Quality Council

- Supply Chain: Through document review, oversight on material receipt, deviations, change controls

- Manufacturing: Through document review, oversight on review of MFG batch records, deviations, change controls

- Quality Control: Through document review, oversight on QC testing, OOS, deviations, change control

- Facilities: Through document review, oversight on GMP area, equipment maintenance, training

- Princeton Quality Unit:

• Supportive team member Site Quality Council Consults with QA team members on decision making steps and escalates to QA management any quality problem occurred in the course of his/her activity.

- Communication

• After reported to his/her Management and ensured about the legal protection of any confidential information disclosure, may communicate with the external vendors and partners.

• After having double-checked what is required to disclose strictly and ensured that any communication is compliant with the established framework.

• By written (or confirmed in writing ASAP), when the communication contains confidential information and ensured of the good tracking of this communication.

Halo Pharma Whippany, NJ 11/17-6/19

Quality Assurance Inspector

• Responsible for performing duties related to but not limited to In-coming materials (i.e. sampling, review specification and release materials in SAP and any other related electronic database).

• Perform line Inspections in SDF, Santyl and Packaging lines.

• Review batch records when required.

• Perform all quality assurance activities in accordance with cGMP and standard operating procedure.

• Perform review of C of A or C of C for in-coming materials, verify the shipments meet Halo requirements, and notify Management of any discrepancies.

• Perform all sampling of raw materials, packaging components and printed material following Halo SOP, ANSI, CFR and EHS guidelines.

• Perform review of QC Specification; ensure all test result met specifications requirements and release of incoming materials, packaging components and printed materials in the electronic data base.

• Assign retest or expiry dates as per SOP.

• Apply stickers to identify the materials status.

• Perform QA inspection as per batch record in SDF, packaging lines adhering to all GMP and EHS guidelines.

• Work in a sterile environment.

• Review packaging and manufacturing batch records, perform calculations and yields.

• Perform AQL inspection and correctly identify a defect.

• Review and release bathes in SAP for shipment.

• Assist with other QA related tasks as delegated by QA Manager.

• Completes TrackWise assignments.

• Other duties as assigned.

Progenitor Cell Therapy Allendale, NJ 9/13-10/17

Quality Assurance QA/QC

• Participate in the execution and documentation of process validations.

• Maintain and gather data and investigate relative to customer complaints.

• Inspecting/sampling raw materials, incoming components, in-process product, and finished product plant according to documented specifications.

• Review maintain equipment and cleanroom logbooks.

• Assist in maintaining the quality management system to be in compliance with the current and applicable FDA GMP Regulations.

• Assist in the documentation and resolution of nonconforming material reports and process discrepancy reports.

• Assign ECC, OSS, VP and VP-P's.

• Track and maintain Adverse Reactions, EM Excursion and Personal Monitoring, for cleanrooms and equipments.

• Verify the calibration of all inspection test equipment and maintain accurate records.

• Calculate and verify component usage at the end of production runs.

• Perform AQL sampling, pre-approval inspections and maintain accurate records.

• Assist in the generation and resolution of corrective and preventive action plans (CAPAs)

• Generate controlled labels as needed using programs provided. Document same using proper approval forms and paperwork to issue and return materials from the Label Control Area.

• Assist in material flows required to maintain label control operations including consolidation, relocation,

and other practices.

• Maintain work area orderliness and cleanliness.

Aphena Pharma - Whippany, NJ 12/12-8/13

QA/QC Inspector

• Participate in the execution and documentation of process validations.

• Assist in the generation and resolution of corrective and preventive action plans (CAPAs).

• Assist in maintaining the quality management system to be in compliance with the current and applicable FDA GMP Regulations.

• Inspecting/sampling raw materials, incoming components, in-process product, and finished product plant according to documented specifications.

• Environmental and Plant Auditing

• Review all documents prior to the start of production and complete first piece approval (FPA) as required.

• Review and inspect labels for approval

• Record data and maintain accurate records in accordance with GMP good documentation practices.

• Troubleshoot quality concerns that may arise on the production floor.

• Prepare shipments to include required internal paperwork, pallet shipping documents & labeling, customer email notices.

• Review all paperwork, including device/drug history records (DHR), daily for accuracy and completeness.

• Verify the calibration of all inspection test equipment and maintain accurate records.

• Gather data and investigate relative to customer complaints.

• Calculate and verify component usage at the end of production runs.

• Perform AQL sampling, pre-approval inspections and maintain accurate records.

• Assist in the documentation and resolution of nonconforming material reports and process discrepancy reports.

• Generate controlled labels as needed using programs provided. Document same using proper approval forms and paperwork to issue and return materials from the Label Control Area.

• Assist in material flows required to maintain label control operations including consolidation, relocation,

and other practices.

• Maintain work area orderliness and cleanliness.

ITC (International Technidyne Corporation) - Edison, NJ 5/10-11/11 (Contract)

Quality Control Technologist

• Worked with hemoglobin testing system and the protime microcogulation system for prothrombin time patient self testing and for professional use.

• Performed testing of biological raw materials and finished goods.

Performed required testing for product validation and process validation on existing product and prepare reports.

• Performed testing for investigation of non-conforming materials.

Time off to raise twins 2007-2009

Geritrex - Mt Vernon, NY 11/04-10/07

QA/QC Inspector/ Batch Record Clerk

• Responsible for inspecting machines.

• Performed label and package. inspection/audit while on production floor

• Performed inspections on raw materials, finished products and ran test samples on finished product.

• Responsible for calibrating scales and gauges.

• Assisted in analytical, retain, and micro testing for in-process and finished products

• Responsible in making sure rooms and equipments are clean according to SOP standards.

• Discarded rejected goods

• Maintained quality control quarantine areas

• Reviewed documents for accuracy and GMP compliance.

• Made sure batches are to current specification to insure the quality.

• Insured batch records are signed and filled and all calculation are correct.

Nyack Hospital - Nyack, NY 05/01-10/03

Unit Assistant

• Responsible for filling, faxing, answering phones, data entry, patient billing, serving meals for patients, making patient charts and typing consent forms.

Novartis Pharmaceutical - Suffern, NY12/99-02/01(Contract Kelly Services)

Quality Assurance/ Package Line Operator

• Responsible for inspecting tablets for defects and performed physical testing.

• Assisted in analytical, retain and micro testing for in-process and finished products.

• Perform label inspection and approval.

•Package audits while on production floor.

• Responsible for scale calibration.

• Ran packaging line.

• Made sure clean rooms and equipments are clean according to SOP standards.

• Maintained quality control quarantine areas.

• Reviewed documents for accuracy.

• Worked with production to resolve issues with batches.

• Insured batch records are signed and filled and all calculations are correct.

EDUCATION:

04/04-06/04 Samaritan Hospital Suffern, NY Certificate in Patient Care

07/00-03/03 Nyack Hospital Nyack, NY Certificate in Administrative Assistant

09/96-6/99 Ramapo High School Ramapo, NJ

SKILLS:

Computer skills: Microsoft Word, Word Perfect, SAP, Excel, Medical Manager, QAD, Qt9,TrackWise,and Netsuite.

Basic lab equipment skills: Using a AQL, CBC machine, FACS Calibur flow machine, pipettes, centrifuges, microscope, Biological Safety Cabinets, CO2 incubators, waterbaths, and Vi-Cell (automated cell counter).

Knowledge of Medical Terminology, GMP, SOP and FDA regulations.

Contact this candidate