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15 days old

Quality Assurance Scientist

Kelly Services
Manatí, PR 00674
**Quality Assurance Scientist**


Supports manufacturing operations areas (OSD and Parenteral product) such as Compounding, Filling, preparation, capping, Inspection, compression and packaging to assure that appropriate cGMPs are in place through frequent operations audit.

Manages audit observations, investigations and CAPAs records in Trackwise on timely manner and participates in the investigations management process to identify root cause, evaluate and approves Corrective and Preventive actions (CAPAs) and provides appropriate recommendations for the lot disposition. Reviews and approves the investigations occurred in the manufacturing process (OSD and Parenteral products), facility and utilities, microbiology and warehouse areas.

Reviews and approves the master documentation related to manufacturing and support areas such as CRs, SOPs, WPPs, BOMs, qualification and validation Protocols with government regulations and company Policies. Provides technical guidance and compliance support in the transfer of new products and process to maintain quality standards. Manages audit observations, investigations and CAPAs records in Trackwise on timely manner. Reviews and approves equipment, utilities and facilities qualification and system life cycle documentation.

Reviews and approves all executed batch production records and laboratory testing records before release of the product for distribution to assure that no deviations have occurred, or if deviations have occurred, that they have been fully investigated. Reviews and approves all process, product and computer systems validation protocols and reports, change control documentation, redressing / reprocessing / rework operations, investigation reports related to manufacturing process and microbiology laboratory, and Annual Product Quality Review (APQRs) elements.


Requirements:


Bachelor Degree in Science, Chemical Engineering, Biology, Pharmacy or Microbiology.

3 years of experience in the pharmaceutical industry.

Minimum 1 year of experience in Quality Assurance responsibilities in a pharmaceutical industry.

Knowledge of manufacturing operations of Solid Dosage and Parenteral Products Manufacturing.

Fully bilingual (Spanish/English) communication skills, both written and verbal are required.

Proficient knowledge of computer systems (Microsoft Office, etc.) and applications like Trackwise and SAP.

Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results.



**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-07-25 Expires: 2022-08-25

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Quality Assurance Scientist

Kelly Services
Manatí, PR 00674

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