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22 days old

Manager, Quality Assurance Scientist

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


Accountable for assuring that the manufacturing and/or support areas operations (Sterile, Non-Sterile, QC Laboratories, Warehouse, Engineering, Supply Chain, MS&T, IM, among others) are performed in compliance with domestic and international cGMP regulations, and company policies and procedures and for providing scientific approach and Quality assurance direction to the approval of the GMP documents such as batch records, forms, protocols, procedures, qualification, and validation reports. Enforce critical analytical thinking in the investigation management process specifically during root cause analysis, risk assessment evaluation and corrective and preventive actions determination to guarantee that gaps are properly addressed.


Interfaces directly with manufacturing and/or support areas operations to ensure that appropriate procedures are in place, through the execution of thorough reviews of procedures against practice.

Leads and participates in the critical review of all documents associated with the manufacturing and/or support areas operations, release, packaging and relevant activities in the operations areas.

Ensures that deviation on documentation dealing with OOS or process parameters outside filing or validation are investigated and resolved by thoroughly reviewing timely corrective actions.

Provides key technical guidance and oversight to manufacturing and/or support areas operations areas (Sterile, Non-Sterile, QC Laboratories, Warehouse, Engineering, Supply Chain, MS&T, IM, among others to assure the appropriate cGMPs are in place through quarterly, monthly, weekly, or daily operations audits, as applicable.

Ensures compliance of all procedures (SOPs) to avoid potential regulatory and compliance issues; including GDP and electronic systems compliance.

Provides scientific input into investigations management to assure root cause and CAPAs are aligned with the opportunities identified in order to perform a systematic approach.

Supports actively the investigation processes in manufacturing areas (Sterile and Non Sterile) and support areas such as Warehouse, QC laboratories, IT, MS&T, facilities and utilities providing coaching from Quality perspective. Provides guidance on gaps identified from the review and actively participates to determine potential remediation activities. Supports risk analysis process when required per procedures. Evaluates product impact and provide lot disposition recommendation when an investigation is completed as needed. Manages audit observation, investigations, change control and CAPAs records in applicable QMS on timely manner. Provides technical guidance and quality assurance support in the transfer of new products and process to maintain quality standards.

Participates in Manufacturing Alignment Teams (MAT) and Project Alignment Teams (PAT), department staff, planning and change control board meetings, as required.

Evaluates documentation compliance, including data GDP compliance and electronic system data compliance, and its overall management requirements for all manufacturing and support areas, including QC laboratories, such as CRs, SOPs, BRs, Forms, Logbooks, BOMs, WPPs, qualification and validation Protocols, according with government regulations and company Policies.

Provides support to the area QA Leader during the budget preparation activities.



Requirements:


Bachelor Degree in Science (Chemical, Engineering, Biology, Pharmacy or Microbiology) with six (6) years of experience in Quality Assurance responsibilities in a pharmaceutical industry, or Doctoral Degree (PhD) in Pharmacy with valid License in Pharmacy (Good Standing and / or without Restrictions of Puerto Rico Board of Pharmacy).

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

Strong knowledge of relevant GMP, FDA, EU regulations and the ability to interpret and apply them for intended use

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

Proficient knowledge of problem solving and root cause analysis methodologies (i.e. Kepner Tregoe)

**_Willing to work irregular hours, rotative shifts, weekends and holidays when needed_**


**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: 2022-06-06 Expires: 2022-07-07

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Manager, Quality Assurance Scientist

Kelly Services
Manatí, PR 00674

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