What are the responsibilities and job description for the Formulation Manufacturing Associate position at ELITechGroup Inc.?
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.