Formulation Manufacturing Associate

ELITechGroup - A Bruker Company; Bothell (WA); On-site; USD 36,000 - 47,000; Full time

Job summary

ELITechGroup - A Bruker Company is seeking a biochemical manufacturing support role to formulate oligonucleotide probes and assays, manage inventories, and assist with regulatory documentation in a cGMP environment.

The candidate will dissolve, dilute, and label products, prepare samples for Mass Spectrometry, and maintain lab equipment while contributing to process improvements and SOP updates.

Qualifications

• Bachelor's degree in a scientific discipline with 0-3 years in an FDA-regulated environment, preferably manufacturing or quality control.
• General computer skills using various software applications.
• Experience with NAV software is a plus.

Responsibilities

• Dissolves and dilutes oligonucleotide synthesis products; analyzes concentration; formulates assays (RUO/ASR/EUA/510K); labels products.
• Formulates solution mixes per SOPs and worksheets to prepare finished products.
• Prepares and submits oligo samples for Mass Spec analysis.
• Manages oligo stocks inventory and assists with RUO/ASR/EUA/510K product inventory.
• Manufactures stocks of raw materials and buffers; maintains lab supplies.
• Calibrates and maintains lab equipment as required.
• Updates and writes manufacturing SOPs, SEPCs, worksheets, and related docs to ensure cGMP compliance.
• Initiates and owns quality records (NCs, CAPA) and supports process improvements.

Skills

NAV

General computer skills

Education

Bachelor's degree in chemistry or related field

Tools

Mass Spectrometer

Spectrophotometer

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.

• 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.


• 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.

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.

Salary: $30 per hour