Analyst, QC I

Job Title : Analyst, QC I

Duration : 12 months, 40 hrs / week

Location : Novato, CA

Duties :

Perform, under minimal supervision, physical, chemical and biochemical analyses of incoming raw materials under cGMP to meet specified timelines.

Evaluates data against defined criteria / specifications.

Maintains proficiency in a broad range of trained test methods.

May train technicians and other analysts in areas of expertise.

Collaborate with co-workers to appropriately share general housekeeping activity assignments and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness.

Evaluate results and trend data.

Maintain raw materials log and control of laboratory inventories.

Coordinate and track outside laboratory testing activities.

Coordinate and track incoming samples from vendors for qualification purposes

Participate in the preparation of investigations, summaries and reports.

Must have a quality service attitude and be willing to work additional hours to meet production or laboratory requirements when necessary.

On rare occasion, provide on call coverage for Out of Specification conditions to support production testing and quality control laboratory equipment.

Develop familiarity concerning cGMP, 21CFR, USP, EP, JP and ICH regulatory requirements.

Interacts with other departments at Client as appropriate.

Assists in revision of written procedures as assigned.

Holds self and others responsible to abide by department and company policies and practices.

Maintain the laboratory in an inspection ready state.

Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures, perform initiation of investigation records within required timeframes.

Perform other duties as assigned.

Skills : Required Skills :

Must have a positive, team minded personality

Demonstrated working knowledge related to specific functional activities.

Ability to perform most tasks with moderate supervision.

Computer literacy is required.

Experience with Microsoft Word and Excel required; experience with Labware LIMS, a plus.

Must have excellent record keeping, written and verbal skills.

Work in a GMP laboratory and be compliant with the laboratory procedures.

May work with biohazardous materials, hazardous chemicals, and radioactive materials.

Comfortable lifting 50 pounds.

Ability to work independently and to deal with multiple tasks.

May be required to work second shift, overtime, weekends and holidays.

Moderate supervision and minimal guidance should only be necessary for specific ad hoc assignments.

Organizational skills as well as good written and verbal communication skills essential.

Must work effectively as a member of the Client team.

Must have a Quality service attitude and be willing to work additional hours to meet deadlines and requirements.

Desired Skills :

Experience in a cGMP laboratory; quality control experience beneficial.

Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices preferred

Familiarity / experience with Compendial testing (USP, EP, JP) preferred

Familiarity / experience with complex instrumentation (HPLC, GC) preferred

Familiarity / experience with Labware LIMS preferred

Education :

B.S. / B.A. in Science (major in biology-biochemistry-chemistry or related field) with at 0 - 1 years of relevant laboratory experience or A.S. with at least 2 years of relevant laboratory experience.