Marc Booker

Senior Quality Head Consultant

Marc Booker is a high-level expert, that works in Torque main office of which is in 518. on the position of Senior Quality Head Consultant since 2019. This person gained professional experience in more than 37 positions at various companies. Marc Booker went to the Arizona State University and received education from 2015 to 2016. Las Vegas, Nevada is the city, where this expert was known to be settled. The professional's email address and phone are accessed through this website on demand.
Name variants:
Mark Booker
Last updated Jun 05, 2024

Contact Information

Last Update
Jul 7, 2022
Email
ma**@hotmail.com, mb**@amgen.com
Location
Las Vegas, NV
Company
Torque

Workplace

Senior Quality Head Consultant

Work History

Senior Quality Head Consultant

Cambridge, MA
from Sep 2019

Director of Quality

from Sep 2019

Senior Quality Compliance Consultant - Brammer Bio

168 3Rd Ave, Waltham, MA 02451
Oct 2018 — Aug 2019

Quality System Implementation

★ QMS Implementation - Help manage time lines/deliverable, also assist in tracking/helping obtain any approvals for documentation that are needed. ★Review and update documentation and traini...
2018 — 2018

Quality System Implementation Pm Consultant

1000 Winter St, Waltham, MA 02451
★ QMS Implementation - Serve as a project manager within the project and help manage time lines/deliverable, also assist in tracking/helping obtain any approvals for documentation that are n...
Oct 2017 — May 2018

Global Design Compliance Consultant

345 east Main St #p/o box 708, Warsaw, IN 46580
Zimmer Biomet is the world's most trusted brand for personalized bone and joint healthcare solutions. We help people discover and achieve exceptional outcomes. As a leading innovator in musc...
Oct 2016 — Jul 2017

Site Quality Operations -Consultant

★ Acts as liaison between Global Quality Assurance and suppliers throughout the EMA certification manufacturing process. ★ Leads and facilitates multi-disciplinary work sessions to get ali...
Aug 2016 — Oct 2016

Quality Compliance Consultant

121 Seaport Blvd, Boston, MA 02210
★ Acts as liaison between US Quality Assurance and suppliers throughout the Quality Agreement negotiation process. ★ Management, control, and communication of multi-department (commercial, c...
Mar 2016 — Jul 2016

Principal Owner Compliance X Consulting Inc

Boston, MA
from Nov 2014

Quality Investigations and Organization Advisor Global Gxp Consulting

★ Served as a coach and mentor to address critical non-compliance issues, while performing root cause analysis and creating corrective action plans to avert operator error and manage deviati...
Jun 2014 — Nov 2015

Quality Systems

★ Spearheaded the creation and documentation of formal MDRs, complaint investigations, CAPAs, non-conformances, and change controls based on the identification of root causes of manufacturin...
Dec 2013 — Apr 2014

Quality Assurance Pmp

★ Served as Project Manager in charge of the creation and deployment of an in-house stability program to replace outsourced stability programs that were ineffective. ★ Delivered project mile...
Jun 2013 — Dec 2013

Senior Qa Compliance Auditor

331 Treble Cove Rd, North Billerica, MA 01862
★ Managed the review of documents to ensure compliance with FDA, EU, and cGMP requirements. ★ Led periodic and annual product quality reviews to ensure compliance with quality standards; ide...
Jul 2012 — Mar 2013

APR

Jul 2012 — Mar 2013

Purification Senior Specialist Investigations

50 Binney St, Cambridge, MA 02142
★ Worked with FDA-appointed agents to ensure compliance with company guidelines and regulations by reviewing deviation investigations and CAPA documentation. ★ Created an environment of team...
Jun 2011 — Mar 2012

Consultant

Framingham, MA
Jun 2011 — Mar 2012

Senior Quality Engineer

New Jersey
Ensured that all validation documentation meets external regulatory and internal WWQC guidelines and requirements. Provided document review and approval for Processes, Equipment, Computer an...
Oct 2010 — Jun 2011

Quality Engineer Specialist, Consultant

Oct 2010 — Apr 2011

Biotech Investigations

Oct 2010 — Apr 2011

Biotech

BMS
Jan 2010 — Oct 2010

Quality Assurance Operations Senior Specialist, Consultant

Lexington, MA
Jan 2010 — Oct 2010

Senior Qa Ops Specialist Ii

Attending cross functional meetings where QA input and oversight is required Review and approval of User Requirement Specifications, Impact Assessments, Design Reviews, Validation Protocol...
Jan 2010 — Oct 2010

Quality Assurance Ops Senior Specialist II, Consultant

Marietta, PA
Sep 2009 — Dec 2009

Shire HGT

Sep 2009 — Dec 2009

Senior Qa Ops Specialist Ii

Gsk
★ Contributed to the company’s response to the H1N1 pandemic, supporting quality functions related to the validation, production, and release of an AS03 adjuvant. ★ Reviewed Master batch rec...
Aug 2009 — Jan 2010

Director Quality Assurance, Consultant

Canton, MA
Jun 2008 — Jul 2009

Biotech

GSK
Jun 2008 — Jul 2009

Consultant

★ Built the Quality unit and organizational structure from the ground up, innovating standard operating procedures, test methodologies, and contamination procedures. ★ Assessed all lab funct...
2008 — 2009

Senior Quality Assurance Manager

1 Amgen Center Dr, Thousand Oaks, CA 91320
★ Hired, managed, trained, scheduled and promoted career development of QA professionals and auditors responsible for cGMP and Quality Assurance Unit (QAU) audits for site QA and vendors. ★ ...
Feb 2003 — Oct 2008

Quality Assurance Senior Manager

West Greenwich, RI
Feb 2003 — Oct 2007

Quality Assurance Senior Manager

West Greenwich, RI
2003 — 2007

Quality Assurance / Manufacturing Manager

Wharton, NJ
Mar 2001 — Mar 2003

Quality Assurance / Manufacturing Manager

Wharton, NJ
2001 — 2003

Biotech Investigations Leader

2000 — Jun 2014

Senior Quality Auditor, Consultant

2000 — Jul 2012

Consultant Projects and Responsibilities

2000 — 2008

Senior Manager

1 Amgen Center Dr, Thousand Oaks, CA 91320

Education

2015 — 2016
Jan 1, 2014 — Dec 31, 2015
2014 — 2016

Master of Science in Biologics

South Carolina
from 2013

Master of Science in Biological Sciences

from 2012
Jan 1, 2008 — Dec 31, 2012

Bachelor of Arts in Social Science

Occupations

Executive
Director
Counselor
Operations Manager
Advisor

Skills

Validation
Gmp
Capa
Fda
Pharmaceutical Industry
Quality Assurance
Change Control
Quality System
Biotechnology
Gxp
Quality Auditing
21 Cfr Part 11
Process Improvement
Deviations
Management
Cross Functional Team Leadership
Sop
Quality Control
Biopharmaceuticals
Technology Transfer
Trackwise
Lims
V&V
Aseptic Processing
Auditing
Computer System Validation
Pharmaceutics
Regulatory Affairs
Cgmp Practices
Sop Development
Training
21 Cfr
Regulatory Requirements
Remediation
Erp
Software Documentation
Iso
Data Analysis
Change Management
Lean Management
Health Canada
Isotrain
Batch Records
Batch Release
Documentum
Apqr
Apr
Pqr
Ich Guidelines
Consent Decree

FAQs about Marc Booker

What's the profession of Marc Booker?

This professional's job is Senior Quality Head Consultant

What are the profession of Marc Booker?

These person's professions are Executive and Director

Where is Marc Booker located?

The professional is located in Las Vegas, Nevada.

What is the professional's email?

Marc Booker's email is ma**@hotmail.com and mb**@amgen.com.

Where did Marc Booker work?

Marc Booker worked at Torque, Repertoire Immune Medicines.

What education does Marc Booker have?

Marc studied at the Arizona State University from 2015 to 2016.

Are there any industries, that Marc Booker is connected to?

This professional works in Pharmaceuticals industry.

Are there any professional skills Marc Booker has?

Marc Booker has such skills as Validation, Gmp, Capa, Fda, Pharmaceutical Industry, Quality Assurance, Change Control, Quality System, Biotechnology, Gxp, Quality Auditing, and 21 Cfr Part 11.
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