Scientist Jobs

Manufactures in-vitro diagnostic products (controls and calibrators) used in the clinical laboratory, following cGMP. Completes associated manufacturing documentation and participates in continuous improvement projects.

Key responsibilities:

* Manufacture bulk products and perform testing using chemistry clinical analyzers

* Completes manufacturing batch records and MPIs, ensure compliance at all times in accordance with cGMP including GDP

* Meet on-time delivery dates for each assigned work order and adhere to production schedule

* Review and analyze data

* Weighing, transfer, mixing of chemicals required

* Initiates non-conformance reports as required

* Perform product filtrations

* Review and approve completed batch records

* Maintain and analyze lot histories for trends and discrepancies

* Assist with modifying SOPs, work instructions and reports

* Recommends improvements to processes, environment or equipment

* Participate in daily/weekly lab '5s' activities

* Keep department lead or manager updated on all issues

* Monitor stocks of common lab supplies

* Perform other job duties as required

Minimum requirements/qualifications:

* BS/BA in scientific discipline (chemistry/biochemistry) with 0 - 2 years related experience and/or training preferred.

* Equivalent combination of education and years of related experience may be substituted.

Experience:

• IVD manufacturing experience is a plus

Knowledge, Skills, Abilities:

• Laboratory skills and knowledge of safety precautions is a plus

• Experience in working with potentially hazardous chemicals and human source materials is a plus

• Familiarity with Quality System Regulations and ISO 13485 regulations is a plus

• Must be able to lift 25 lbs routinely

• Must perform tasks in compliance with GMP, GDP, QSRs, ISO and IVD regulations

• Strong laboratory skills including pipetting, safety, and hazardous chemical handling

• Must be organized and detail oriented to be able to prioritize own and other’s work and meet business productivity metrics

• Self-sufficient, self-motivated, and focused