QC NPI QC Compliance & Documentation Specialist (Regular)

:

• Manage the documentation, reordering and correct storage of the Reference Standards and reagents of the DPS laboratory;

• Perform queries, with the frequency established by the procedures, to guarantee the availability of Std/ Reagents from the DPS chemical laboratory;

• Ensure the resolution of problems with suppliers and those presented by analysts;

• Collaborate with the T Ls of the DPS Chemical Laboratory to ensure the correct management of Reference Standards and DPS laboratory reagents

• Ensure documentation verification of standards/reagents for DPS Audits ( Regulatory/ Corporate and Customer Audits).

• Contribute to the successful outcome of regulatory and customer inspections by responding directly to requests made in the field and during the review of the required documentation in the room.

• Guarantee the correct and timely movement of the material, temporarily stored in the warehouse awaiting registration in the system, from the warehouse to the laboratory

• Ensure verification of adherence to the Pharmacopoeias and evaluation in case of updates relating to the job performed

• Update department-specific procedures

• Ensure management of safety data sheet and carcinogenic reagent deadlines

• Participate in updating the department's SO Ps at the request of the manager.

• Ensure that training packages are kept up to date with those assigned to the role.  

EH&S:

- Understand emergency procedures and comply with safe systems of work.

- ensure compliance with environmental

- prompt reporting any near misses and breaches of rules

Minimum requirement:

- high school or degree in scientific discipline would be an advantage

- ability to work under critical timelines

- effective communication skills at all internal and external levels

- excellent attention to detail

- excellent organization skills

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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