QA Specialist shft 5 pm to 530 am 35165

Integrated Services For Productivity & Validation, Inc

Job Location:

Juncos - Puerto Rico

Monthly Salary: Not Disclosed

Experience Required: 4-5years

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job Summary

Execute Quality disposition (approval or rejection) of bulk drug substances.

Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug Substance (API) are manufactured tested stored and managed according to current Good Manufacturing Practices (cGMP) Good Laboratory Practices (cGLP) and other applicable regulations.

Ensure that deviations from established procedures are identified reported and documented per procedures.

Ensure that changes that could potentially impact drug substance quality are assessed according to procedures.

Ensure that production records and testing results are complete accurate and documented according to written procedures and cGMP requirements.

Ensure that facilities equipment materials organization processes and procedures align with cGMP practices and other applicable regulations.

Champion continuous improvement initiatives programs and projects including developing efficiency projects and supervising progress.

Ensure completion of required training and maintain assigned training adherence to support successful task execution.

Collaborate and partner cross functionally to ensure the Quality Management System (QMS) processes are completed in accordance with established procedures.

Support internal and external audits and inspections as part of the audit/inspection management team including acting as Quality Unit representative as needed.

Alert senior management of quality compliance supply and safety risks.

Provide support and oversight for New Product Introduction (NPI).

Requirements

Doctorate degree or Masters degree and 2 years of Quality or Manufacturing support experience in pharmaceutical GMP regulated environment

or Bachelors degree and 4 years of Quality Manufacturing support experience in pharmaceutical GMP regulated environment

or Associates degree and 8 years of Quality or Manufacturing support experience in

pharmaceutical GMP regulated environment

or High school diploma / GED and 10 years of Quality or Manufacturing support experience in pharmaceutical GMP regulated environment

Educational background in Life Sciences and/or Engineering. Expertise in Quality Systems including Deviations (Non conformities) CAPA and Change Control.

Experience with key electronic systems such as documentation platforms (e.g. CDOCS) Maximo TrackWise LIMS MES/electronic batch record systems and SAP.

Experience in computer systems validation (CSV) or computer systems quality assurance including consulting level technical proficiency.

Experience with validation of GxP applications including Validation Master Plans GxP risk assessments IQ/OQ/PQ protocols test scripts and summary/approval reports.

Robust knowledge of manufacturing and distribution processes including QA QC and Process Development operations.

Validated experience serving as Quality Contact for complex projects involving packaging inspection commissioning qualification and new drug Night Shift: 5:00pm-5:30AM/products.

Strong organizational skills with the ability to drive assignments through successful completion.

Demonstrated leadership influencing and negotiation skills including interactions with regulatory agencies and evaluation of compliance issues.

Strong communication skills (written and oral) facilitation abilities and full bilingual proficiency in English and Spanish with the ability to work independently and effectively across all organizational levels.

Execute Quality disposition (approval or rejection) of bulk drug substances. Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug Substance (API) are manufactured tested stored and managed according to current Good Manufacturing Practices (cGMP) Good Lab...