Specialist QA

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• Perform one or more of the following duties and responsibilities in support Quality Assurance program under minimal supervision.
• Perform review, approval and tracking of cGMP processes, procedures, testing (methods) in manufacturing, documents and records, batch record review, MES, EBR, SAP, Trackwise; including but not limited to Deviation’s, CAPAs, and validations.
• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Release of sanitary utility systems.
• Represent QA on NPI team.
• Designee for QA manager on local CCRB.
• Support Automation activities.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records. Approve change controls.
• Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
• Demonstrate ability to interact with regulatory agencies.

Qualifications:

• Bachelor's degree 
• Five (5) years of directly related experience.
• Experience in batch record review, DAI process and to be familiar with in PASx/MES application, MAXIMO, SAP and LIMS.
• Quality Professional with Manufacturing Process Audit and Batch Record Review experience.
• Project management skills
• Validated expertise in Quality Systems such as Non-Conformance, CAPA, and Change Control
  Experience in computer systems validation or computer systems quality assurance (medical device and/or consulting background technical proficiency)
• Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development
• Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements
• Validated experience as Quality Contact for complex projects involving packaging, inspection, and new products.
• Validated experience in Commissioning and Qualification
• Available for non-standard shift/Available to work 1st, 2nd and 3rd shift.
• 1st shift: 5:30am-2pm/2nd Shift: 1:30pm-10pm/3rd shift: 9:30pm-6:00am.