Formulation Manufacturing Associate

Summary

Formulates oligonucleotide probes, primers and assays (RUO, ASR, EUA & 510K). Manages oligo stocks inventory. Assists Manager in managing RUO, ASR, EUA and 510K products inventory.

Essential Duties and Responsibilities

• Dissolves and dilutes oligonucleotide synthesis products, analyzes concentration, formulates assays (RUO, ASR, EUA & 510K), prints labels according to specifications and apply labels to product tubes.
• Formulate solutions mixes according to SOPs and Work Sheets (WS) to prepare finished products.
• Prepare and submit oligo samples for Mass Spec analysis.
• Manages oligo stocks inventory.
• Assists Director/Manager in managing RUO, ASR, EUA and 510K products inventory.
• Manufactures stocks of raw materials and buffers, and maintains lab supplies, etc.
• Calibrates and maintains lab equipment as required.
• Makes inventory corrections and consumptions in NAV.
• Writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements. Edit SOP, SEPC, Work Sheet and related documentation when needed.
• Initiating and owning quality records, including but not limited to non-conformances (NC), Corrective/Preventative (CAPA).
• Provides input to process improvements and assists with the development of new and/or improved manufacturing procedures.
• Assists with related special projects, as required.

Qualifications

•Bachelor's degree (B.S.) in a scientific discipline (chemistry, molecular biology, biochemistry or related field) from four-year college or university with 0-3 years of experience including relevant industry experience in an FDA regulated company preferably in manufacturing and/or quality control.

•General computer skills utilizing various software applications.

•Experience in NAV

Preferred

•Experience with Mass Spectrometer and/or spectrophotometer plate reader.

•Proven knowledge of cGMP requirements to ensure compliance.