Qa/ra Specialist

Description:

We are working with our client MMQCI in seeking a QA/RA Specialist 1, to be based in the Saco Maine

Requirements of the QA/RA Specialist I:

· Bachelor of Science degree in Life Sciences and 5+ years of employment in a cGMP regulated facility and 2+ years of experience in Quality Assurance/Regulatory Affairs

· Must be a nonsmoker due to product contamination prevention requirements.

· Vaccinations for Covid required, and a test within one week including results reported prior to starting work.

· Knowledge of current GMP regulations is required.

· Knowledge of ISO 13485 is preferred.

· Strong skill in utilizing Microsoft Office software (Excel, Word, Outlook) is required.

· Excellent proof-reading skills are required.

· Highly detail oriented with the ability to multi-task in a changing environment.

· Experience in laboratory medicine is highly preferred.

· Good communication skills, written and oral.

· Technical writing skills preferred.

· Ability to meet challenging timelines, despite obstacles.

· Willingness to learn and pitch in as part of team.

· Capable of rapidly developing sufficient expertise to function independently.