Manufacturing Chemist
Cliniqa Corporation (San Diego, California)

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Manufacturing Chemist, Manufacturing

Cliniqa is currently seeking a Manufacturing Chemist to work in the Manufacturing Department.  This is a full time position.  The right candidate will have 2-10 years similar work experience. 

Qualifications:

Bachelors Degree preferably in chemistry, biology, biochemistry or related field with experience in an in vitro diagnostic, medical device, pharmaceutical or related industry.  Detail oriented.  Ability to show initiative and to perform in a multi-task environment.  Good interpersonal, verbal and written communication skills.  Ability to work with personnel of all levels.  Ability to perform in a GMP and GLP environment.  Knowledge of QSR and ISO.  Familiarity with biohazardous material handling and chemical safety procedures. 

Responsibilities / Essential Functions

The primary objective of position is to formulate controls and calibrators for the medical diagnostic industry.  The Manufacturing Chemist must have a strong understanding of the key techniques used in the manufacture of control and calibrator type products for IVD industry as well as have the ability to interface with team members of various levels.

q  Processing of human source controls and calibrators following work order documents, which may include centrifugation, the use of chemicals to formulate products and the formulation of buffers and solutions.

q  The Manufacturing Chemist works independently, exhibiting the ability to make judgments regarding solutions to manufacturing challenges. 

q  Assist in the development of procedures to support the manufacture of new products to meet company objectives and timeline.

q  Work closely with Lab Techs to complete projects according to Production Schedule.

q  Validation testing of new and existing equipment and processes.

q  Assist with overall maintenance of laboratory equipment as necessary.

q  Perform material testing in accordance with pertinent work instructions and SOPs using automated diagnostic instruments.

q  Perform centrifugation, and diafiltration as required by manufacturing protocols.

q  Accurately document performed tasks according to accepted QSRs.

q  Participate in Manufacturing Meetings

q  Assist Process Development Department with the transfer of technology to Manufacturing

q  Maintain work areas in a clean and professional manner.

q  Work with the Manufacturing Manager to develop efficiency concepts for formulation processes.

q  Assist in defining, implementing and verifying cost containment or reduction strategies

For over 25 years, CLINIQA has earned an enviable track record within the IVD industry by manufacturing and marketing high quality products, designed to improve the accuracy of diagnostic tests. CLINIQA operates from three facilities in San Diego County in Southern California. CLINIQA's Quality Management Systems are certified to ISO 9000 and EN 13485 Standards.