Resume

Sign in

Manager Quality

Location:
Emmaus, PA
Salary:
$145 K
Posted:
March 05, 2019

Contact this candidate

Resume:

Jessica Haas

ac8oj4@r.postjobfree.com

Emmaus, PA

484-***-****

Overview:

Quality Manager with over 13 years of management and laboratory GxP experience in a pharmaceutical environment. Motivated, self-starter, highly organized, quick learner, dependable, strong team player with excellent communication skills.

Core Qualifications:

Quality Management (QC, QA, QS)

Risk Management

Complaint Management

Document Authoring and Management

Change Management

Validation (Process, cleaning, test method, computer systems, spreadsheet)

Regulatory / Customer Audit Hosting

Internal Audits

21CFR Parts 11, 58, 210, 211, 820, MHRA and HACCP compliance, 503B Compounding

Quality Metrics

Vendor Management

Sterility Assurance

Leadership

Analytical Skills

Interpersonal Skills

Time Management

Communications Skills

Batch Record Review

CAPA

Calibration

IQ/OQ/PQ

Deviation Management

OOS and Laboratory Investigation

Skills:

Proficient in Microsoft Office

Laboratory Experience:

HPLC (Shimadzu, Agilent, PerkinElmer Series 200)

FTIR (Bruker Alpha, PerkinElmer Paragon 500)

TOC (Shimadzu)

Particle Size Analyzers (MicroTrac, Malvern, Air Jet Sieve, Ro-Tap)

Density determination (Auto-Tap)

Loss on drying (Denver IR-120, Denver IR-200)

UV/VIS Spectroscopy (PerkinElmer Lambda 10)

Gas Chromatography (GOW-MAC series 350)

Professional Experience:

QuVa Pharma – Bloomsbury, NJ

October 2018 – February 2019

Manager, Quality Systems - Laboratory

Responsible for ensuring that all laboratory investigations are conducted in compliance with internal procedures and FDA regulations.

Laboratory Investigations into OOS, atypical results, trends and deviations for both internal and contract laboratories performing analytical testing

Audits of laboratory systems to ensure compliance and data integrity

Implementation of CAPAs based on conclusions of investigations

Ensure housekeeping, instrument calibrations, preventative maintenance, training and GDP follow procedures and meet regulatory requirements.

Review and approval of IQ/OQ/PQ for laboratory equipment

Gap assessments and analysis of data to drive improvement

June 2018 – September2018

Manager, Manufacturing Quality Assurance/Sterility Assurance/ Lot Disposition

Responsible for all aspects of quality and sterility assurance in compounding, testing, packaging, labeling, batch release and shipping of sterile injectables.

Hired and managed a manufacturing QA team providing learning and development where appropriate

Make QA decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations

Create/revise SOPs

Review and approval of Deviations/Investigations, CAPAs, Change Controls and IQ/OQ/PQ

Process improvements to maintain compliance with FDA 503B and cGMP guidelines / state and federal laws

Batch record review and disposition of bulk and finished compounded sterile products (CSPs)

Design and maintain the environmental / personnel monitoring and trending of related data

Periodic review of records to verify that quality standards for each drug product is met

Lonza Pharma & Biotech (formerly Capsugel and Powdersize) - Quakertown, PA

October 2005 – April 2018

Quality Manager

October 2015 – April 2018

Responsible for all aspects of quality control and quality assurance for the particle size engineering of food, excipient, API and drug product intermediates.

Implemented Active Learner, TrackWise, Documentum, part 11 compliant software across all laboratory equipment, a Validation program for equipment and computer systems, a HACCP program, a risk management system and change control.

Authored/approved validation, quality and analytical documents.

Authored SOPs and forms for Quality and Production.

Managed QA and QC team, assign responsibilities, interview, hire and assist with training new employees.

Managed the QC laboratories.

Hosted Regulatory and Customer audits.

Set annual goals and continuous improvement initiatives.

Performed data integrity and part 11 compliance gap assessment.

Batch record review and batch release.

Interacted with the cross-functional teams.

Assistant Quality Manager

December 2011 – October 2015

Authored/approved laboratory investigations, deviations and OOS investigations.

Authored/approved SOPs, forms, validation protocols and reports.

Batch record review

Testing and sampling

Senior Quality Technician / Quality Technician

June 2008 - December 2011 / October 2005 – June 2008

Implemented EtQ Reliance Document Control (configuration, validation)

Tested samples: particle size (MicroTrac, Malvern, air jet sieve, Ro-Tap), density (Autotap), moisture analysis (loss on drying), identity (FTIR), residual (TOC, HPLC)

Sampled for microbiological testing: environmental monitoring, water, air, product contact and non-product contact surfaces.

Test method development and validation testing

Authored SOPs, forms, validation protocols and reports.

Batch record creation

Shipping and receiving

Giant Food Store - Allentown, PA

Assistant Bakery Manager / Bakery Associate / Pricing Coordinator

April 2002 - October 2005

Trained new employees, ordering, customer assistance, price changes, preparing and printing price change signs.

McDonald’s - Allentown, PA

Supervisor

August 1999 – March 2002

Trained new employees, maintained schedules, responsible for controlling inventory, customer assistance.

References available upon request



Contact this candidate