QC Associate

Responsibilities:

• Excellent employment opportunity for a QC Associate in the Fremont, CA area.
• Reviews raw material lot packages and releases RM lots for GMP manufacturing use.
• Ensures lot release timelines will be met and coordinates testing performed at in-house and contract laboratories.
• This includes, but not limited to, preparation of sample submission forms, performing necessary LIMS and SAP transactions, review of test records, tracking status of samples and their respective tests, etc.
• Review, author, and edit documents, including deviations, change control requests, SOPs, test methods, material specifications, analytical investigations, and laboratory test plans and related technical reports.
• Interacts with functional groups within and outside of QC and recognition of issues that require elevation to upper management.
• Performs tasks and activities related to supplier/material qualifications and supplier change notifications (e.g., review of vendor documentation, review of vendor and material history, etc.)
• Performs logbook and/or LIMS entries when using equipment/instruments.
• Reconciles samples.
• Perform weekly and monthly reviews of appropriate forms (e.g., test records) and logbooks.
• Assists with QC's data management, including data review and trending.
• Maintains specific QC files and database records for process and/or quality improvement efforts.
• Maintain laboratory cleanliness and orderliness.
• Cross-train in other RM duties to cover for other RM members when needed.

Experience:

• Bachelors' Degree
• Six (6) years of cGMP or appropriate experience are required.
• Knowledge of ANSI/ASQ Z1.4, DIN ISO 2859 or other sampling standards is required.
• Strong technical writing required Knowledge of CFR, USP, and ICH required.
• Knowledge of SAP, Trackwise, and LIMS desired.
• Working knowledge of Microsoft Office systems, LIMS, lab instrumentation, and other relevant systems
• Highly productive, attention to detail, ability to manage time and prioritize tasks with input from manager to meet timelines.
• Demonstrated problem-detection and problem-resolution skills required
• Physical Demands / Surroundings: Lifting, carrying, pushing or pulling up to 50 pounds occasionally
• Frequent periods of sitting, walking, and standing
• Occasionally must climb stairs or ladders, balance, bend or stoop, crouch or squat
• Occasional low-level work, fine finger dexterity/ including grasping or pinching required
• Writing and use of a computer keyboard frequently
• Occasional use of personal protective equipment
• Required Skills: LIMS, DATABASES, TRACKWISE, SOP, GMP
• Additional Skills: ICH/GCP, MICROSOFT OFFICE, ANSI, CHANGE PROCESS MANAGEMENT, CHARTING, DATA MANAGEMENT, RECONCILIATION, SAMPLING

Job Type: Contract

Salary: $25.00 - $35.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Fremont, CA: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• Manufacturing: 5 years (Required)
• ICH Guidelines: 1 year (Required)
• lab instrumentation: 1 year (Required)
• Laboratory information management systems: 1 year (Required)
• Quality control: 1 year (Required)
• Documentation review: 1 year (Required)

Work Location: One location