Associate Process Group Chemist

Description:

SUMMARY OF POSITION

The Associate Process Group Chemist, in accordance with forecasted requirements, participates in the manufacture of products within QSR and ISO regulations. This position reviews and reconciles documents and work orders, supports assigned projects with supervision, participates in product transfers, supports departmental troubleshooting and process improvement teams, and displays an improving working knowledge of business processes as they relate to manufacturing.

ESSENTIAL FUNCTIONS

Manufactures (i.e. Formulates bulks, and Quality Controls) products (i.e. Lateral flow devices, controls/calibrators and microtiter systems) while adhering to regulatory requirements and business polices/procedures and schedules Supports departmental troubleshooting and process improvement teams Supports cross-functional projects and training. Reviews completed Device History Records, performs financial review of work orders, and reports on variances to supervisor Maintains daily adherence to Production goals relating to MUV/LUV, labor utilization, work order closure, and schedule adherence

INTERACTIONS

Associate Process Group Chemist may have interaction with the following groups/systems.

Typically with supervision:

Inventory Control obtains/returns materials, resolve material variances related to work order usage LN

• reconciles work orders, enters/checks labor hours, checks material availability, BOMs, general manufacturing queries, and closes work orders; prepares work order variance reports. Process Engineering
• technical troubleshooting, product transfers Production coordinates optimization/matrix assembly Planning
• reports on schedule adherence Quality/Documentation
• ECO's, NCMR's, deviations, validations, QTP's

WORK ENVIRONMENT

The work environment characteristics are representative of a laboratory environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines.

PHYSICAL DEMANDS

Position requires ability to lift up to 20 lbs. on a regular basis. Up to 75% of time at lab bench or desk, walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must have the ability to operate lab equipment. Position requires use of Personal Protective Equipment as posted.

EDUCATION, SKILLS & EXPERIENCE

Education and Experience

B.S./B.A.

Life/Applied Sciences or equivalent experience Preferred minimum of 6 months of related work experience in a GMP environment Knowledge/Skills Basic algebraic, statistical and mathematical skills General computer knowledge Good organizational skills Laboratory skills, such as protein purification, antibody conjugation, solution preparation ELISA experience, assay development skills, etc. Good verbal and written communication skills Good interpersonal skills Knowledge of QSR's and

ISO 9001

Knowledge of experimental design Basic Chemistry or Biochemistry

AFFIRMATIVE ACTION/EQUAL OPPORTUNITY STATEMENT

Quidel is proud to be an Affirmative Action/Equal Opportunity Employer (Minorities/Women/Disabled/Veterans). We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

OTHER DUTIES

Please note that this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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