Formulation Manufacturing Associate

ELITechGroup; Bothell (WA); On-site; USD 55,000 - 75,000; Full time

Job summary

ELITechGroup seeks an entry‑level Manufacturing/Quality Associate to support oligonucleotide synthesis, formulation, and inventory management in a regulated environment.

You will assist with RUO/ASR/EUA/510K product inventories, prepare samples for analysis, and help maintain SOPs and quality records in accordance with cGMP requirements.

Qualifications

• Bachelor's degree in a scientific discipline with 0-3 years in an FDA regulated environment.
• Experience in manufacturing or quality control within a regulated setting.
• Proficiency with standard computer software and NAV familiarity.

Responsibilities

• Dissolve and dilute oligonucleotide products, analyze concentration, and formulate assays per SOPs.
• Prepare finished products, calibrate equipment, and maintain lab supplies.
• Manage oligo stocks inventory and assist with RUO/ASR/EUA/510K product inventories.
• Create and update manufacturing SOPs, work sheets, and related documentation.
• Initiate and own quality records including CAPA and NC.
• Support process improvements and participate in related special projects.

Skills

Computer skills

NAV experience

Education

Bachelor's degree in scientific discipline

Job description

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.