Quality Assurance Technician

Edward Campbell

Email: *********@********.***

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

City: Johnston

State: RI

Zip: 02919

Country: USA

Phone: 401-***-****

Skill Level: Experienced

Salary Range: 65

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Edward Campbell

16 Argonne Street Johnston, RI 02919

401-***-**** *********@********.***

MANUFACTURING PURIFICATION ASSOCIATE

PROFILE

Highly experienced Biotech Manufacturing Purification specialist with the ability to successfully execute multi-tasked responsibilities while exercising Good Manufacturing Practices (cGMP). Practiced at enforcing the federal regulations necessary for the manufacture of Biotech products. An accomplished professional with demonstrated success in all aspects of practical manufacturing operation and administration.

Progressive experience in all areas of buffer, media prep, glass wash, purification, and fermentation, with advanced mechanical ability. Displays significant levels of dedication, accuracy, motivation, and independence, resulting in exceptional productivity.

Able to focus and work well in high-pressure situations, constantly seeking new challenges, a driven individual with both a strong work ethic and the desire to exceed expectations in all aspects of endeavor.

Success-oriented professional possessing an extensive knowledge of the processes, procedures and policies necessary to consistently produce a safe, superior Biotech product.

CORE COMPETENCIES

Process Analysis * Problem Resolution * Process Improvement * Purification

Federal Pharmaceutical Laws and Regulations * LIMS * Glass Wash

Buffer Prep * Media Prep and Harvest * Fermentation, Delta-V Automation

PROFESSIONAL EXPERIENCE

Merrimack Pharmaceuticals (contract)Cambridge, MA 2010

Purification Technician

For a biopharmaceutical manufacturer of autoimmune and cancer medicines, ran a small scale downstream process

Using a Delta V DCS Controller. Prepared small scale buffers with an electric magnetic steer plate, revising Standard Operating Procedures (SOPs), as needed. Performed buffer washes and elutions on final product. Bottled, labeled, and delivered final product to QA for final testing.

Followed batch records and revisions in accordance with the SOPs.

Monitored all log books for errors.

Ipsen Pharmaceuticals (contract) Milford, MA 2010

Purification Temporary Operator

For a global biotechnology specialty care group, loaded product over purification columns. Operated a skid process for a series of buffer washes using various buffers. Performed Elution and Filtration and filled vials in a clean room environment.

Packaged final fill product and shipped it the warehouse, providing Quality Assurance with samples. Followed all SOPS and safety regulations, including gowning.

Edward Campbell Page 2

Xcellerex, Inc. (contract)Marlborough, MA 2010 - 2010 Production Technician

For a single-use biotheraputics and vaccine manufacturer, performed Media Harvest and Re-feed on a 10L Bioreactor.

Monitored GMP Suite Biobag Reactors. Re-supplied areas with required equipment and materials. Operated Delta-V and Siemens DCS Automated Controllers.

Abbott Laboratories Worcester, MA 2009 - 2010

Senior Purification Technician

Provided operation and use of Ultrafiltration Skid, Cleaning, and Storage. Prepared Solutions and Equipment in a timely manner for production needs. Deployed CHROMAFLOW Fixed Adaptor Column Preparation, Packing, and Inspection. Loaded Product over Columns, performed Buffer Washes and Elutions. Steam sterilized filters and Stainless Steel Mobile Vessels. Rendered Filtration and Bagging of QXL Concentrate. Oversaw Bulk Fill Suite Bottling Operations. Operated and cleaned Biological Safety Cabinets. Utilizing current cGMP training.

Performed Filter Integrity Testing, Cleaning in Process, and Steaming in Process on all vessels and transfer lines. Reviewed documentation prior to submitting to Quality Assurance. Used bench top equipment consisting of PH Meters and Conductivity Meters to test samples from completed batches in Buffer.

Amgen Inc. West Greenwich, RI 2001-2009

Purification/Buffer Associate II / Shift Lead

Was involved with the new product start-up project in Buffer Prep. Worked with contractors and validation team during start-up phase using diagrams and production suite IDs. Initiated, revised and completed new SOPs for production start-up. Trained new employees and coordinated shifts. Prepared buffers for production needs in a timely manner. Cross Trained in Purification and became a member of the Purification team for several years. Monitored and operated waste water treatment systems, water for injection systems, Meco Still Operations. Media batch maker (large and small scale). Prepared all solutions in 8000, 4000, and 600 liter stainless steel vessels used in production.

Weighed and mixed raw materials. Performed manual cleaning, CIP, SIP, sanitation, and sterilization of all vessels and transfer lines. Operated autoclaves, depyrogenation ovens, P.H. meters, scales, and conductivity meters.

Burroughs / Wellcome Pharmaceuticals West Greenwich, RI 1992 - 2001

preparation unit. Prepared product load, buffer washes, sanitization, sterilization, filter integrity testing, and elution of primary and secondary product using aseptic technique following updated cGMP SOPs. Sampled product for bioburden counts.

Fermentation: operated centrifuges, bioreactors, and harvest vessels. Performed monitoring, cell counts, sampling, P.H. adjustments, and sterilization of all vessels and product transfer lines. Performed Media Feeds and Harvest.

Participated in the Lock-Out / Tag-Out Policy and Procedure as well as using Status Tags and Solution Labels.

Took samples of product during operations and used Laboratory Information Management System (LIMS).

Protein Purification Unit Operator / Fermentation Technician

Received thorough training in primary and secondary purification. Sanitized affinity gel in chromatography columns

Graduated High School in 1983: Cranston High East, Cranston, RI, 02910 References at request.

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