Quality Control Assurance

Dennis N. Carmichael

* ****** **. # * *****, MA *1970

978-***-**** ****************@*******.***

Relevant Qualifications

Quality Control manager with six years supervisory experience running cGMP laboratories in

support of an international commercial pharmaceutical product.

Hands on analytical chemist with a broad understanding of techniques and equipment.

Fully capable of handling assignments involving detailed record keeping, analysis, reporting

and efficiently following projects to completion.

Well organized, with excellent written and oral communication skills.

A document author and reviewer with significant knowledge of Pharmacopoeias and

Regulatory requirements for Biologics, including laboratory SOP’s, validation documents,

and regulatory sections.

The ability to effectively hire, train and manage staff.

Direct interface with regulatory inspectors during audits

Experience

Biopure Corp., Cambridge, MA

Assistant Manager / Senior Supervisor Quality Control September, 2004 – June, 2008

Responsible for all aspects of the Quality Control analytical and raw materials laboratories in

Cambridge and PA. Assure that the laboratories meet all the standards required by GMP,

GLP, FDA, EMEA, USP and ICH regulations and guidelines. Ensured Quality Control

readiness across three shifts to support manufacturing operations with 24 hour / 7 day

coverage. Review and trending of all in-process and release data for drug products and

finished goods. Review and trending of utilities and environmental monitoring data. Primary

contact with contract laboratories performing outsourced testing (US and UK based). Work

with other departments and outside vendors on stability programs, new product testing and

method development and transfer. Worked on the creation and implementation of the CAPA

system for the investigation and resolution of OOS and OOT. Work closely with QA to

assure that production lot records and stability testing results are reviewed and completed in

a timely fashion. Fully trained to be acting microbiology supervisor. Additional duties as

listed below.

Quality Control Supervisor March, 2002 – September, 2004

Supervision of Quality Control analysts, including scheduling, performance review and

interviewing new candidates. Perform in process, final product and stability sample analysis

in support of production. Techniques include HPLC (Millennium and Empower), SEC,

Osmolality, TOC, Gas Chromatography, Co-Oximetry, UV/Vis Spectrophotometery, FTIR,

Endotoxin, ELISA, Conductivity and pH. Validation and maintenance of laboratory

equipment. Interface with other departments for scheduling and problem solving. Ordering

supplies and equipment to assure the lab is operating at peak efficiency.

Dennis N. Carmichael

Collagenesis Inc., Beverly, MA

Lead Quality Control Chemist and Calibration Officer March, 1998 – December, 2001

Supervision and scheduling of QC chemists. Ordering supplies, materials and equipment for

QC laboratory. Performing analysis of raw materials, in process and final products as

needed. Maintain files and database of all QC results. Prepare periodic reports detailing QC

results. Scheduling of outside vendors for equipment calibration. Assuring that all calibrated

equipment is calibrated and within tolerances. Maintain calibration files and database.

Quality Control Chemist September, 1997 – March, 1998

Perform analysis on raw materials, in process and final product. Techniques used included

Spectrophotometery, Osmolality, Differential Scanning Calorimetery, pH, Conductivity, SDS-

Page, Percent solids using microwave system and wet chemistry. Collect and analyze utility

and environmental monitoring samples. Train new QC chemists. Write and review Standard

Operating Procedures. Write and perform validation protocols. Training as an internal

auditor.

Quality Assurance Support May, 1997 – September, 1997

Receive and log raw materials. Review of production personnel and documents to assure

procedures were followed. Write and review SOPs for both Quality Assurance and Quality

Control. Responsible for document control. Trained to work in a Class 1000 clean room.

Computer Skills

Highly skilled in Microsoft Word, Excel, Access and Outlook

Have used JMP Statistical Software

Education

University of Massachusetts at Dartmouth, N. Dartmouth, MA

BS Marine Biology

Florida Atlantic University, Boca Raton, FL

Post Graduate studies in Marine Biology

North Shore Community College, Danvers, MA

Concentration in Biotechnology Applications. Techniques included but not limited to: PCR,

Gel Chromatography, ELISA, Western Blot Electrophoresis, Transformation and Genetic

Engineering.

References

Available on Request

Contact this candidate