Quality Control Microbiology Analyst
Biopure Corporation (Nasdaq: BPUR) is the leading developer, manufacturer
and supplier of a new class of pharmaceuticals, called oxygen therapeutics,
which are intravenously administered to deliver oxygen to the body's tissues
as a sterile alternative to red blood cell transfusion. Biopure's oxygen
therapeutics possess unique attributes that address many of the medical and
logistical issues associated with red blood cell transfusions. The company
believes these attributes may enable its products to be used as high-value
therapeutics to provide oxygen-carrying support, or an Oxygen Bridge(tm), in
a broad range of potential medical applications.
The QC Microbiology Analyst will be responsible for conducting routine and
non-routine product testing. Will review all test documentation and
initiate and update standard operating procedure revisions.
* Conduct routine and non- routine product testing including USP/EP
Sterility testing, Bioburden testing Water testing, and Biological Indicator
testing per Biopure SOP's.
* Work in accordance with all internal and external regulatory bodies
including GMP, ICH, and Biopure SOP's.
* Maintain lab, including maintenance of equipment, lab supplies as
well as general lab organization.
* Maintain trending spreadsheets and related documentation in
accordance with GMP.
* Review all test documentation. Initiate and revise SOPs, protocols
and final reports.
* Conduct all tasks associated with Microbial Identification and
Environmental Monitoring. Provide monthly trending of routine environmental
* Work on projects including Process Validation, Protocol initiation,
and final report generation.
* Train other Microbiology Laboratory employees.
* Conduct QC testing for media and supplies.
* Job Requirements:
* Bachelors/Masters degree in a scientific discipline or equivalent
with a minimum of 3 years experience within a pharmaceutical microbiology
laboratory with a Bachelors, or 1 year with a Masters.
* Basic computer skills including MS Excel and Word.
* Lift up to 25 pounds, climb ladders, sterile gowning and aseptic
fill suite operations.
* Strong attention to detail.
Please fax, email or mail resume to: Job Code: JF, Human Resources
Biopure Corporation, 11 Hurley St., Cambridge, MA 02141 Fax: 617-234-6830
Email: resume at biopure.com Website: www.biopure.com