Manufacturing Process Chemist

Title: Manufacturing Process Chemist
Location: Carlsbad CA 1^st Shift
Duration: 9 Months

Summary:
The Associate Process Group Chemist in accordance with forecasted requirements participates in the manufacture of products within QSR and ISO 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 - ECOs NCMRs deviations validations QTPs

Job Description:
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.

Skills Required:
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 QSRs and ISO 9001
Knowledge of experimental design
Basic Chemistry or Biochemistry

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.

Education: College graduates preferred