MARC BOOKER

Email: abqe9o@r.postjobfree.com

Address: *** ****** ****** **** ***

City: WHITMAN

State: MA

Zip: 02382

Country: USA

Phone: 508-***-****

Skill Level: Management

Salary Range: $100,000

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Marc Booker

501 Auburn Street unit# 104 Whitman MA 02382

Cell: 508-***-**** Email: abqe9o@r.postjobfree.com

Executive Summary:

Self-motivated, team-player and diligent professional pursuing a Master's Degree in Biological Sciences combined with superior analytical skills and technical expertise encompassing cGMP, GLP, and GXP concepts. Equipped with extensive biotechnology and Quality background complemented with in-depth understanding of process analytical technology. Capable of building rapport with management and colleagues from all levels underscored by the ability to simplify and communicate complex scenarios. Adept at working in an environment requiring problem resolution, with proven effectiveness to multitask in a competitive, high-impact, and fast-paced environment while juggling with multiple priorities simultaneously with good judgment. Utilize strategic planning and decision-making skills in streamlining business processes and defining improvement processes to ensure efficiency.

CORE COMPETENCIES

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, Deviations/CAPA, CCMS, QCDS, QACMS, LMS, Maximo, Livelink

Excellent problem solving skills; both inter-personal and analytical

14 years of supervisory and management experience

Pharmaceutical, Bio Pharmaceutical, Chemical and Cosmetic background

Ability to lead and motivate staff as well as to 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, 211,210, 600

Experience in monitoring the performance of current suppliers

Aseptic techniques experience

Amgen certified internal and external auditing

PROFESSIONAL EXPERIENCE

Senior Quality Auditor, Consultant

Lantheus Medical Imaging Billerica, MA JUL 2012 to present

Ensure documents follow FDA, EU and cGMP requirements as well as conduct annual or periodic product quality reviews

Review of Change Controls for consistency and compliance

Analyze Lantheus products/raw materials and explain trends, including justification of assessments and conclusions

Purification Senior Specialist - Investigations, Consultant

Genzyme Framingham, MA JUN 2011 to MAR 2012

Ensured that all Deviations/CAPA documentation and investigations met external regulatory and internal guidelines and requirements. Worked with FDA appointed agents for consistency as well as documentation and investigational improvements

Participated in the creation of a team-based environment, promoting candor, collaboration, and receptivity, clarity of purpose and goals, and high commitment to achieve business goals. Demonstrated appropriate examples of compliance behaviors and attitudes

Quality Engineer Specialist, Consultant

Bristol Myers Squibb Devens, MA MA OCT 2010 to APR 2011

Ensured that all validation documentation met external regulatory and internal WWQC guidelines and requirements. Provided document review and approval for Processes, Equipment, Computer and Analytical validation, commissioning and qualification documentation from both technical and compliance perspectives

Performed Risk Assessments. Reviewed validation-related testing. Assured consistent, effective use of the site change control system for all change requests

Participated in the creation of a team-based environment, promoting candor, collaboration, receptivity, clarity of purpose and goals, and high commitment to achieve business goals. Demonstrated appropriate examples of compliance behaviors and attitudes

Reviewed and approved SOPs. Provided compliance review for Computerized Maintenance Management System (CMMS). Participated as requested in the response team for audits and inspections by world health authorities

Quality Assurance Operations Senior Specialist, Consultant

Shire HGT Lexington, MA JAN 2010 to OCT 2010

Attended cross functional meetings where QA input and oversight was required. Reviewed and approved User Requirement Specifications, Impact Assessments, Design Reviews, Validation Protocols, Validation Reports, SOPs, and Master Batch Records.

* Support of the establishment and execution of Quality Metrics and Quality Systems

Reviewed and approved GMP design and qualification Lifecycle documents (e.g. URS, impact assessments, IOQs, PQs). Reviewed and approved GMP operations documents such as batch records

General QA support and guidance on quality issues and adherence to internal quality procedures and policies.

Support of quality systems execution (e.g. Deviations, CAPA(s), Investigations, etc)

URS, SLA. P&ID. IOQ. PQ. PV

Quality Assurance Ops Senior Specialist II, Consultant

Glaxo Smith Klein Bio Marietta, PA SEP 2009 to DEC 2009

Provided support on quality activities for the validation, production, and release of AS03 adjuvant for H1N1 pandemic event

Reviewed and approved Master batch records, procedures, deviations, internal change controls, corrective and preventive actions

Provided mechanism for isolating and/or quarantining equipment, facilities, or materials that failed to meet required specifications

Conducted deviation investigations when assigned, to allow for dispositions of lots, approving return-to-use for quarantine materials, or return-to-service orders for production equipment and facilities following completion of investigations

Worked with operations, maintenance, quality, and engineering teams on quality improvement projects or corrective actions

Periodically reviewed discrepancies to identify problem areas in the Marietta facility and recommended corrective actions where appropriate

Performed preventative failure analysis

Performed a quality review and approved maintenance work orders

Participated in instrument calibration assessments

CAPA - Change Controls - Product Investigations- Deviations

FDA - EU audits

Director Quality Assurance, Consultant

Harrison Specialty Company Canton MA JUN 2008 to JUL 2009

Responsible for building the Quality unit and organizational structure. Ensured the laboratory functioned under cGLP requirements and the facility functioned under cGMP requirements. Set up standard operating procedures and test methods. Developed training qualifications and Quality Systems to ensure compliance. Prepared Company for PAI inspection as well as developing an internal audit program. Instrumental in the direction of new hire requirements as well as retraining current employees. Involved in customer audits as well as vender qualifications. Validation review of IQ-OQ-PQ protocols and reports. Set-up contamination procedures and an investigations team to handle in house issues.

Quality Assurance Senior Manager

AMGEN West Greenwich, RI FEB 2003 to OCT 2007

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. Ensured appropriate and effective cross-training in compliance 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 determined approach to managing daily quality operations

Interpreted and executed policies that directly affected work activities

Developed and communicated plans/objectives to others

Set project timeframes and priorities based on project objectives and ongoing assignments as well as coordination of assignments

Monitored department budgets and goals. Provided guidance and technical advice to staff members as well as client groups. Facilitated Department and QA Mangers meetings

Frequent contact with internal personnel and outside customer representatives at various management levels to obtain and allocate resources and complete specific phases of projects

Accountable for day-to-day Quality operations and responsibilities

Training Head for site Plant Quality Assurance: Responsible for training development and updates.

Able to apply knowledge to provide appropriate risk based decisions

Involved in contamination response meetings as Quality representative

Continued to develop staff into high performers and qualified quality representatives

Validation, SOP, Tech reports, MP reviewer and approver. Applied influence and negotiation skills to drive business results. Involved in FDA audits and costumer complaints

In support of Amgen's Quality Assurance program; management and oversight of the QA operations of a specific functional area in a manufacturing plant

Responsible for hiring, training, supervising and performance management of staff. Performed or oversaw the following functions: Initiated or reviewed change control packages

Reviewed and approved product MPs Review and approve SOPs. Approved process validation protocols and reports for Mfg. processes

Approved Environmental Characterization reports Approved planned incidents Lead investigations, Lead plant audits, participated in site audits, and approved changeover completion

General document coordination and compilation

Compliance review of batch record elements (e.g., MPs, MSRs) and identification of discrepancies

Worked with operations to resolve basic compliance discrepancies .Approve micro. Certificates and ALNs

Disposition of raw materials, components, and labels

Ensured that new hires had the essential tools and resources to do their jobs successfully

Implemented my leadership and communication skills, finding ways to improve new-hires transaction periods, making employees more productive sooner

Maintained a system to accommodate any Amgen or Quality personnel changes i.e. ISOtrain; SOP rev(s), Master Record updates

Worked with HR Department to modify ISOtrain for PQA needs for tracking new SOP rev(s) and keeping employee training concurrent by at least 90%

Trained Bio Next personnel involving SOP(s), Databases, and PQA procedures

Set up documented practices for PQA Department, as well as a system to track training of this procedure, assisting PQA personnel and Management on document flow as well as ensuring that new hires had an enhanced perceptive of Amgen(s) practices

Set up Training Qualifications. Collaborated and communicated with higher level outside resources

Ability to evaluate compliance risks. Thorough knowledge of CFRs, GMPs and pharmaceutical processing.

Approved and monitored Supplier CAPA plans

Quality Assurance / Manufacturing Manager

Dimensional Merchandising Inc. Wharton, NJ MAR 2001 to MAR 2003

Maintained the Quality operating procedures of the company and assured the finished products met the customer requirements. Operated as surveillance for management in order to insure that the service, product and reputation of the company were associated with that of superior quality

Conducted periodic audits of the quality systems, operational functions and the Facility to assure management that the highest levels of quality were being maintained

Reviewed all non-conforming materials, found the cause for non-conformance, initiated corrective action and rendered a disposition. Trained new employees on SOP(s), cGMP, Validations, and all current QA and Manufacturing FDA requirements. Maintained quality records to demonstrate achievement of the required quality and the effective operation of the quality system

Working with the Quality Assurance Director, maintained completed Analytical reports for all batches and raw materials. Validated, supervised and planned future and current batches, e.g., Avon, P&G, Calvin Klein, Whitehall Robbins, BD medical devices + 2, + 3 etc. Maintain all Batch documentation concerning issuance of manufacturing and packaging samples, bulk samples for HPLC testing and inspection of all incoming and finished goods

Reviewed and released all batch records under DMI specifications. Developed and lead a Spill Response team; member of the Safety Committee. Involved in Quality Internal, FDA and costumer Audits for improved safety and productivity. Managed QA inspectors as well as Manufacturing Dept. personnel

Provided necessary support for maintenance and distribution of SOP's, Change Controls and any Deviations or Observation documents. Educated Manufacturing personnel re: cGMP compliance

Created and maintained an inventory system for all raw materials, expiration dates and lot numbers

Approved raw materials for batch releases for manufacturing. Tracked 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 days 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

Clemson University Master of Science Biological Sciences 2012-2014 (in progress)

Ashford University, Bachelor of Arts in Social Science minor Project Management

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