Major International Biopharmaceutical Company discovers, develops,
manufactures and markets products that power the immune system to help
people with serious, unmet medical needs. The company has a broad
product portfolio and significant research capabilities focused on
developing and commercializing novel vaccines and antibody-based
therapies that prevent and treat infectious, autoimmune and addictive
diseases, such as Staphylococcus aureus and hepatitis infections, ITP
and nicotine addition.
Description: The QA Specialist position will be responsible for the QA
oversight of the manufacturing process and areas in our Boca Raton
facility. The QA Specialist contributes to overall planning especially
regarding clinical operations and marketed products. It reviews Batch
Production Records (BPRs) and Standard Operating Procedures (SOPs),
Deviations, EDRs, Change Control, OOS, Lookback and NCMR
documentation, and may also review and approve buffer preparation
records. It also reviews, processes and approves
lookbacks,reviews,revises and processes product specification changes,
and assists in the preparation and review of Certificates of Analysis.
Background/ Education: A High School diploma is required. A BS degree
in Chemistry, Biochemistry, Microbiology, Immunology, or other related
technical fields is preferred. A minimum of 1 to 3 years experience in
the pharmaceutical, biotechnology or medical device industry is
preferred. Excellent writing and communication skills are essential to
the job function, as is the ability to discuss fundamental technical
and regulatory issues within a multidisciplinary environment.
This is a third shift position.
Send your resume to
Andre Papp
Ph: 305.944.3294 ext: 100
Fax: 305.944.3712
andre at computer-careers.com
