Manager Quality Assurance Scientist

• Bachelor's Degree in Life Science and six (6) years of experience in Quality Assurance within the pharmaceutical industry.
• Shift: Available to work irregular hours, holidays, weekend.
• Bilingual: (English/ Spanish) communication skills, both written and verbal.
• Experience in:

• Manufacturing operations of Oral Solid Dosage and Parenteral Products.
• GMP, FDA, EU regulations.
• QA oversight manufacturing
• Batch Record review and Protocol review
• CAPA, Change Control and Annual Product Review

• Being self-motivated means that you are curious, anxious to explore all possibilities without anyone telling you to (while also following instructions, of course). It means you’re creative, with such an eye for detail that nothing gets past you. If this sounds like you, and if you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we’re looking for!

• Interface 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, and 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 (SOP’s) 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 be 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.

Flexible & Integrated Technical Services, LLC