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Manager Manufacturing

Location:
Worcester, MA, 01607
Posted:
July 04, 2014

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Resume:

DENNIS BOAKYE YIADOM

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

Worcester MA 01603

********@*****.***

774-***-****

OBJECTIVE

To build and develop an extremely knowledgeable and efficient team that is

able to meet not only current daily demands of GMP production but to go

beyond this by helping to advance manufacturing systems that will improve

the delivery and overall quality of the products we produce.

SUMMARY OF QUALIFICATIONS

. Over 4 years of experience in the relevant field

. Deep knowledge of manufacturing Techniques

. Through understanding of aseptic terms supported by cGMPs and SOPs

. Excellent ability to write simple correspondence

. Excellent communication and writing skills

. Excellent ability to apply common sense to carry out simple

instructions

. Having job skills to learn company policies and procedures to complete

tasks

PROFESSIONAL EXPERIENCE

Genzyme Corporation, Northborough MA

March 2013 to July 2014

Packing and labeling (Engineering)

. Perform data collection and analysis in support of Label Pack Value

Stream projects and assist in Validation activities for new equipment

. Collaborate with Packaging Manager, Engineering Manager, engineers and

other SME's to develop documentation for new technology driven systems

and drive updating of current documents to changes

. Manage large numbers of Standard Operating Procedure (SOP) changes in

with strong GDP in support of CCR and CAPA

. Perform data collection activities/metrics in support of +QDCI

. Work with Manager to identify and trend key metrics for functions

Skills

. Strong attention to detail and analytical skills

. Excellent communication and interpersonal skills

. Desire to work in a team environment

. Knowledge of Good Manufacturing Practices

. Experience with MS Office applications such as Excel and Word

. General understanding of FDA regulations for pharmaceutical

advertising and promotion.

Diversify Specialty Pharmaceuticals, Framingham, MA

August 2010 to September 2013

Manufacturing Associate

. Analyzed validation results and compiled data into reports for initial

qualifications and requalification adhering to Good Manufacturing

Practices (GMP) and laboratory safety practices and procedures.

. Provided input to technical composition of standard operating

procedures.

. Generated custom validation protocols, executed protocols and wrote

final reports adhering to cGMPs.

. Reviewed and approved validation documentation. Verification

confidentiality

. Entered key data points from important documents into Excel

Spreadsheets 2007 and 2010.

. Entered client data within spreadsheets.

. Created reports using Microsoft Word and excel 2007 and 2010

. Utilized Livelink system for labelling and compounded and creams.

. Utilized Catsweb for building product information and quality

management of regulations.

. Utilized Filemaker Pro database to manage contacts, tracking of

inventory and to organize projects.

. Performed pH meter calibration and conductivity meter calibrations and

standardizations

. Reviewed batch records and brought corrections to the attention of

fellow associates

. Weighed chemicals and prepped different buffers per batch records

demands

. All these are usually protected by laws such as HIPA.

. Responsible for completing paperwork for each task, cleaning

procedures, aseptic processing techniques.

. Performed cleaning and housekeeping activities for assigned areas as

required to maintain a cGMP environment.

. Coordinated testing schedule with impacted area managers and quality

control based on project needs.

. Provided routine and effective communication with immediate supervisor

and other personnel within the group in addition to outside the

department.

. General understanding of FDA regulations for pharmaceutical

advertising and promotion.

. Knowledge of manufacturing techniques.

Royal Palm Specialty Pharmacy, Webster, MA

May 2007 to August 2010

Preparation Technician

. Compounded creams, suspensions and lozenges under the supervision of a

licensed Pharmacist.

. Entered client data within spreadsheets.

. Cleaned and sterilized processing equipment using automated system.

. Performed work requirements in a responsible manner, in accordance

with SOPs, cGMPs, and established safety procedures in accordance with

OSHA requirements and guidelines.

. Familiarized with "Material Safety Data Sheets" for area chemicals.

. Created reports using Microsoft Word and excel 2007 and 2010

. Daily recording of refrigerator and freezer temperatures where

chemicals are stored.

. Calibration and proper documentation of scales, electronic meters,

etc.

. Followed all safety and USP guidelines for preparation of compounded

medications.

. Maintained excellent working relationships with the FDA, other

regulatory agencies, internal project team members,

collaborators/partners and contract manufacturers

EDUCATION

Bachelor of Sciences

University of Toledo (Public Health) December 2012

TECHNICAL SKILLS

Microsoft Word 2007, 2010 (Expert).

Excel Spreadsheet 2007, 2010 (Expert).

Office functions.



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