Sr. Quality Assurance Scientist
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Job Location:
Manati, us-territories - USA
Monthly Salary:
Not Disclosed
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
For Compliance services in the Quality area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors Degreein ChemicalEngineering Biology or Microbiology Science & six (6) years of experiencein the Pharmaceutical Manufacturing industry.
- Bilingual (English & Spanish)
- Shifts: Administrative and according to business needs.
- Experience in:
- Quality Assurance & cGMP Compliance
- GMP Document Approval
- Investigation & Root Cause Analysis
- Cross-Functional Collaboration
The Personality Part:
- Our Next Piece is someone who treats everyone they meet like family especially our resources clients and team other words being a customer service pro is one of your (many) talents. Being the Piece means youre full of bright ideas and eager to innovate consistentlydeliveringtop-quality results. Are you ready to Be The Piece
AS A PIECE OF FITS YOU WILL: (The day-to-day on the job)
- 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 deviations in documentation related to 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 areaoperations(Sterile Non-Sterile QC Laboratories Warehouse Engineering Supply Chain MS&T IM among others) to ensureappropriate cGMPs are in place through quarterly monthly weekly or daily operations audits as applicable.
- Ensures compliance withall procedures (SOPs) to avoid potential regulatory and compliance issues including GDP and electronic systems compliance.
- Provides scientific input into investigationmanagement to ensure root causesand CAPAs are aligned with the opportunities identified enablinga 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 a quality perspective.
- Provides guidance on gaps identified from the review and actively participates in determining potential remediation activities.
- Supports risk analysis process when required per procedures.
- Evaluates product impact and provides lot disposition recommendations when an investigation is completed as needed.
- Manages audit observation investigations change control and CAPAs records in the applicable QMS on timely manner.
- Provides technical guidance and quality assurance support in the transfer of new products and processes 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 to government regulations and clientsPolicies.
- Provides support to the area QA Leader during the budget preparation activities.
- Evaluates department performance indicators and develops the appropriate corrective actions if needed
- Assists management during internal and regulatory agencies inspections (FDA DEA MCA etc).
- Develops sampling plans based on acceptance quality level criteria when additional or special testing is required.
- Performs trend analysis to provide recommendations in order to improve the process and /or the product quality.
- Supports Media Fill activitiesto ensure that both typical and atypical interventions are performed as established.
- Supports the Annual Product Review elements for Quality events of manufacturing and environmental monitoring.
- Evaluates and approves the instrumentation and equipment calibration records and critical area engineering drawings.
- Reviews and approves equipment utilities and facilities qualification and system life-cycle documentation.
- 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.
- Approves or rejects procedures impacting drug products raw material or packaging components.
- Verifies compliance with clients policies and Guidelines.
- Participates as quality representative or liaison in site projects
- Performs pre-operational review form approval in the manufacturing and packaging area.
- Performs shop floor walk-through audits and challenges adherence to area procedures providing coachingand Quality Support in alignment with the business unit to optimize compliance and effectiveness.
- Verifies consistency with other site procedures and/or specifications.
- Reviews and approves investigations related to process products utilities microbiology laboratory and calibrations.
- Approves Corrective and Preventive actions (CAPAs).
- Approves or rejects specifications impacting drug products raw material or packaging components.
- Ensureseffective systems for equipment maintenance and calibration and approvescalibration requests.
- Ensures the designation and monitoring of storage conditions for quarantine materials and products.
- Reviews and approves procedures for processes products utilities and laboratories.
- Maintains management informed (via frequent written reports) of any problem that might affect the quality and/or timely release of materials
WHO WE ARE:
We are a Service Provider companydifferent from the rest. We pride ourselves onhow we treat the most important piece of our companys puzzle: you! We integrate Engineering Construction Maintenance Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible family-oriented and focused on our resources well-being while providing our Pharmaceutical Medical Device and Manufacturing industryclients with top-notch quality talent.Were FITS!
Are you the Next Piece
Required Experience:
Senior IC
