Manager, Quality Assurance Scientist

For Compliance services in the Quality area.

 WHAT MAKES YOU A FIT:  

The Technical Part:

• Bachelor’s Degree in Chemical Engineering, Biology, or Microbiology Science & six (6) years of experience in the Pharmaceutical Manufacturing industry. 
• Bilingual (English & Spanish)
• Shifts: Administrative, and according to business needs.
  • Must be available to support irregular hours if required. 
• 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 members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, consistently delivering top-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 area operations (Sterile, Non-Sterile, QC Laboratories, Warehouse, Engineering, Supply Chain, MS&T, IM, among others) to ensure appropriate cGMPs are in place through quarterly, monthly, weekly, or daily operations audits, as applicable.
• Ensures compliance with all procedures (SOP’s) to avoid potential regulatory and compliance issues, including GDP and electronic systems compliance.
• Provides scientific input into investigation management to ensure root causes and CAPAs are aligned with the opportunities identified, enabling 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 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 CR’s, SOP’s, BR’s, Forms, Logbooks, BOM’s, WPP’s, qualification and validation Protocols, according to government regulations and clients Policies.
• 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 activities to 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 coaching and 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.
• Ensures effective systems for equipment maintenance and calibration, and approves calibration 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 company different from the rest. We pride ourselves on how we treat the most important piece of our company's 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 industry clients with top-notch quality talent. We're FITS! 

Are you the Next Piece?