Marc Booker

940 Quaker lane 2107 Warwick RI 02818

Cell: 401-374-6996 - *Email: (mbebd25c@westpost.net)
________________________________________________________________________________
_____________
Over (15) years of quality experience in the pharmaceutical industry as a Senior
Quality Assurance Manager and Sr. QA Specialist
Objective:
Experienced pharmaceutical professional pursuing opportunities that utilizes my
experience and education. Extensive experience in leading cross functional grou
ps. Extensive experience in manufacturing, technical support, project managemen
t and quality. Proven problem solving and investigative skills. Strong interper
sonal skills. Effective communication with internal and external customers at a
ll levels.
Professional and Personal Skills:
* Excellent Project Management skills, as well as communication, organizational
and oral skills.
* Knowledgeable and compliant with Current Good Manufacturing Practices and Good
Laboratory Practices.
* Computer software knowledge of: Microsoft Excel, Word, PowerPoint, and Sage
* ERP, NC/CAPA, CCMS, QCDS, QACMS, LMS, Maximo etc.
* Excellent problem solving skills; both inter-personal and analytical.
* 14 years of supervisor and management experience.
* Pharmaceutical, Bio Pharmaceutical, Chemical and Cosmetic background.
* Ability to lead and motivate staff as well as manage and distribute workloads.
* Good interpersonal skills with emphasis on cooperation with interdepartmental
teams and matrix management.
* Competency in ISO 9000/9001/13485, 21 CFR 820, 211 AND 210
* Monitored the performance of current suppliers
* Aseptic techniques exp
* Amgen certified internal and external auditing
________________________________________________________________________________
____________
Professional Experience:
Bristol Myers Squibb, Devens MA October 2010 to present (Consultant)
Quality Engineer
* Ensured that all validation documentation meets external regulatory and intern
al WWQC guidelines and requirements. Provided document review and approval for P
rocesses, Equipment, Computer and Analytical validation, commissioning and quali
fication documentation from both technical and compliance perspectives.
* Performed Risk Assessments. Reviewed validation-related testing. Assured consi
stent, effective use of the site change control system for all change requests.
* Participated in the creation of a team based environment, promoting candor, co
llaboration, receptivity, clarity of purpose and goals, and high commitment to a
chieve business goals. Demonstrates appropriate examples of compliance behaviors
and attitudes.
* Reviewed and Approves SOPs. Provided compliance review for Computerized Mainte
nance Management System (CMMS). Participates as requested in the response team f
or audits and inspections by world health authorities
Shire HGT, Lexington MA January 2010 to October 25th 2010 (Consultant)
Quality Assurance Ops Sr. Specialist
* Attending cross functional meetings where QA input and oversight is required
* Review and approval of User Requirement Specifications, Impact Assessments, De
sign Reviews, Validation Protocols, Validation Reports, SOPs, and Master Batch R
ecords.
* Support of the establishment and execution of Quality Metrics and Quality Syst
ems.
* Review and Approval of GMP design and qualification Lifecycle documents (e.g.
URS, impact assessments, IOQs, PQs)
* Review and Approval of GMP operations documents such as batch records
* General QA support and guidance on quality issues and adherence to internal qu
ality procedures and policies.
* Support of quality systems execution (e.g. Deviations, CAPA(s), Investigations
, etc)
* URS, SLA. P&ID. IOQ. PQ. PV
Glaxo Smith Klein Bio, Marietta PA
September 2009 to December 2009 (Consultant)
Quality Assurance Ops Sr. Specialist II
* Support on quality activities for the validation, production, and release of A
S03 adjuvant for H1N1 pandemic event.
* Review and approval of Master batch records, procedures, deviations, internal
change controls, corrective and preventive actions.
* Provide mechanism for isolating and/or quarantining equipment, facilities, or
materials that fail to meet required specifications.
* Conducts deviation investigations when assigned, to allow for dispositions of
lots, approving return-to-use for quarantine materials, or return-to-service ord
ers for production equipment and facilities following completion of investigatio
ns.
* Worked with operations, maintenance, quality, and engineering teams on quality
improvement projects or corrective actions.
* Periodic reviews of discrepancies to identify problem areas in the Marietta fa
cility and recommend corrective actions where appropriate.
* Performs preventative failure analysis.
* Performed a quality review and approves maintenance work orders.
* Participates in instrument calibration assessments.
* CAPA - Change Controls - Product Investigations- Deviations
* FDA - EU audits
Harrison Specialty Company, Canton Mass
June 2008 to July 2009 (Consultant)
Director Quality Assurance (Consultant)
Responsible for building the Quality unit and organizational structure. Ensure t
he laboratory functions under cGLP requirements and the facility functions under
cGMP requirements. Set up standard operating procedures and test methods. Devel
op training qualifications and Quality Systems to ensure compliance. Prepare Com
pany for PAI inspection as well as develop an internal audit program. Instrument
al in the direction of new hire requirements as well as retraining current emplo
yees. Involved in customer audits as well as vender qualifications. Validation r
eview of IQ-OQ-PQ protocols and reports. Set-up contamination procedures and an
investigations team to handle in house issues.
AMGEN -West Greenwich, RI -
Quality Assurance Senior Manager
February 2003 to Oct 2007
Hired, managed, trained, scheduled and promoted career development of QA profess
ionals and auditors responsible for cGMP and Quality Assurance Unit (QAU) audits
for site QA and vendors. Ensured appropriate and effective cross-training in c
ompliance areas. Ensured that all audits were assigned to appropriately trained
auditors, conducted effectively, and reported accurately in a timely manner to
ensure a state of site audit readiness. Instrumental in BLA filing, Validations,
Quality Systems, Training and Quality Procedures.
* Independently determines approach to managing daily quality operations.
* Interprets and executes policies that directly affect work activities
* Develops and communicates plans/objectives to others
* Set project timeframes and priorities based on project objectives and ongoing
assignments as well as coordinate assignments.
* Monitor department budgets and goals. Provide guidance and technical advice to
staff members as well as client groups. Facilitate Department and QA Mangers me
etings
* Frequent contact with internal personnel and outside customer representatives
at various management levels to obtain and allocate resources and complete s
pecific phases of projects.
* Accountable for day-to-day Quality operations and responsibilities.
* Training Head for site Plant Quality Assurance: Responsible for training devel
opment and updates.
* Able to apply knowledge to provide appropriate risk based decisions.
* Involved in contamination response meetings as Quality representative.
* Continue to develop staff into high performers and qualified quality represent
atives.
* Validation, SOP, Tech reports, MP reviewer and approver. Applies influence and
negotiation skills to drive business results. Involved in FDA audits and costum
er complaints.
* In support of Amgen's Quality Assurance program; manages and oversees the QA o
perations of a specific functional area in a manufacturing plant.
* Responsible for hiring, training, supervising and performance management of st
aff. Perform or oversee the following functions: Initiate or review change contr
ol packages.
* Review and approve product MPs Review and approve SOPs. Approve process valida
tion protocols and reports for Mfg. processes.
* Approve Environmental Characterization reports Approve planned incidents Lead
investigations, Lead plant audits, participate in site audits Approve changeover
completion.
* General document coordination and compilation
* Compliance review of batch record elements (e.g., MPs, MSRs) and identificatio
n of discrepancies
* Work with operations to resolve basic compliance discrepancies .Approve micro.
Certificates and ALNs
* Disposition of raw materials, components, and labels.
* Ensure that new hires have the essential tools and resources to do their job s
uccessfully.
* Implement my leadership and communication skills, finding ways to improve new-
hires transaction periods, making employees more productive sooner.
* Maintain a system to accommodate any Amgen or Quality personnel changes i.e. I
SOtrain; SOP rev(s), Master Record updates.
* Work with HR Dept to modify ISOtrain for PQA needs for tracking new SOP rev(s)
and keeping employee training concurrent by at least 90%.
* Train Bio Next personnel involving SOP(s), Databases, and PQA procedures.
* Set up Documented practices for PQA Dept. as well as a system to track trainin
g of this procedure, this will assist PQA personnel and Management on document f
low as well as new hires will have a enhanced perceptive of Amgen(s) practices.
* Set up Training Qualifications. Collaborate and communicate with higher level
outside resources.
* Ability to evaluate compliance risks. Thorough knowledge of CFRs, GMPs and pha
rmaceutical processing
* Approve and monitor Supplier CAPA plans
Dimensional Merchandising Inc. - 86 North Main Street, Wharton NJ
Quality Assurance / Manufacturing Manager
March 2001 TO March 2003
* Maintain the Quality operating procedures of the company and assure the finish
ed products meet the customer requirements. Operate as surveillance for manageme
nt in order to insure that the service, product and reputation of the company ar
e associated with that of superior quality.
* Conduct periodic audits of the quality systems, operational functions and the
Facility to assure management that the highest levels of quality are being maint
ained.
* Review all non-conforming materials, find the cause for non-conformance, initi
ate corrective action and render a disposition. Trained new employees on SOP(s),
cGMP, Validations, and all current QA and Manufacturing FDA requirements. Maint
ain quality records to demonstrate achievement of the required quality and the e
ffective operation of the quality system
* Working with the Quality Assurance Director, maintain completed Analytical rep
orts for all batches and raw materials. Validate, supervise and plan future and
current batches, e.g., Avon, P&G, Calvin Klein, Whitehall Robbins, BD medical de
vices + 2, + 3 etc. Maintain all Batch documentation concerning issuance of manu
facturing and packaging samples, bulk samples for HPLC testing and inspection of
all incoming and finished goods.
* Review and release all batch records under DMI specifications. Developed and l
ead a Spill Response team; member of the Safety Committee. Involved in Quality I
nternal, FDA and costumer Audits for improved safety and productivity. Manage QA
inspectors as well as Manufacturing Dept. personnel.
* Provide necessary support for maintenance and distribution of SOP's, Change Co
ntrols and any Deviations or Observation documents. Educate Manufacturing person
nel re: cGmp compliance.
* Create and maintain an inventory system for all raw materials, expiration date
s and lot numbers.
* Approve raw materials for batch releases for manufacturing. Track all incoming
and outgoing raw materials under FDA regulations, testing and sampling methods.
________________________________________________________________________________
_____________
Accomplishments
Amgen - Lean Management:
* Implemented QA on the floor review which in turn reduced Disposition from 35 d
ays to 15 days
* Reduced Non-Conformances from 60 per batch to 4 per batch
* Rated Exceeds 4 out of 5 years as an exceptional and motivated performer
* Promoted from Supervisor to Senior Manager in a 2 year timeframe.
* Managed staff to operate at a high level of performance
Education:
* Brookdale CC & Trinity University.
* Bachelor of Arts in Social Science minor Biology Ashford University
* ASQ member- Certified Auditor P&G - Amgen
References:
Gary Wolfe: Amgen QA Director: gary.wolfe@comcast.net phone-(815) 933-9662
Michelle Leco: Amgen QA Sr. Asst: mmalette@amgen.com phone - (401)-392-1200
Dana Ottey: GSK QA: Dana L Ottey/PharmBio/GSK@GSK phone - (717)-426-6690
Michelle Bofill: GSK QA: ameivaexsul@hotmail.com phone - (309)-255-8760
Ian O'Reilly: Shire QA: iantoreilly@gmail.com phone - (603) 659-2450