Data Analyst, Oligonucleotide Manufacturing

Job Title : Data Analyst, Oligonucleotide Manufacturing

Job Location : Bothell, WA

POSITION SUMMARY : The Data Analyst is responsible for ensuring quality at the Cepheid Bothell facility by employing best practices to ensure compliance to applicable Cepheid Corporate Quality Polices.

These responsibilities include but are not limited to : oligonucleotide batch record review, record management, process management and improvement of current records and tracking systems.

The analyst works closely with the Oligo Production, Planning and Quality to provide required information about oligonucleotide parts.

ESSENTIAL JOB RESPONSIBILITIES :

Review data in Oligo Manufacturing batch records to ensure all data was entered correctly following GMP.

Maintain a Daily Management tracking system for oligo production status.

Records management; includes filing, logging, tracking, reporting.

Review all records and documents for completeness and compliance with company policies and procedures.

Creating documents, deviations, NCRs, CAPAs and tracking their status.

Support training activities to Oligo Manufacturing personnel and third-party vendors.

Support validation activities for products, processes, equipment and facilities. This includes ordering equipment, review of protocols, protocol execution, deviation investigation and resolution, test results and reports.

Analysis and presentation of oligo manufacturing data on weekly meetings.

Develop and expand upon record keeping pipeline to improve manufacturing efficiency by implementing bar code readers, electronic records, and reducing paper files.

MINIMUM REQUIREMENTS :

Education or Experience (in years) :

Bachelor’s Degree in scientific discipline or equivalent combination of education and experience in a regulated manufacturing environment to perform at this level

Working knowledge of GMP regulations

Experience in a laboratory environment and familiarity with instrumentation and documentation

Knowledge and skills :

Exceptionally strong organization, accuracy, and attention to detail skills required.

Ability to think logically, prioritize tasks, be self-motivated, and work effectively in a team environment

Excellent oral and written communication skills

Excellent knowledge of Excel and electronic management systems (Agile, LIMs, SAP)

Physical requirements / abilities :

Ability to lift up to 20 lbs.

PREFERRED REQUIREMENTS (optional) :

Working knowledge of chemistry or biochemistry lab under a cGMP environment is preferred.