Specialist QA/ PR (Drug Substance) 32900

Job Opportunity: Specialist QA (Drug Substance) 32900

Location: Juncos, Puerto Rico

Period: 1/16/2024 to 6/30/2024

Onsite Job with Non-Standard Shift

No Corp-to-Corp Contracts; Locals in Puerto Rico Only

Educational and Software Requirements:

• Doctorate degree or Master's degree with 3 years of related experience
• Bachelor's degree with 5 years of related experience
• Associate's degree with 10 years of related experience
• Preferred Qualifications: Experience in batch record review, DAI process, and familiarity with PASx/MES application, MAXIMO, SAP, and LIMS.

Description:

Quality Professional with Manufacturing Process Audit and Batch Record Review Experience

Available for Non-Standard Shifts, Including Nights and Weekends

Duties and Responsibilities:

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Request Quality on the incident triage team.
• Approve Environmental Characterization reports.
• Release sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support Automation activities.
• Support facilities and environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment.

Competencies/Skills:

• Project management skills.
• Strong organizational skills.
• Initiate and lead cross-functional teams.
• Enhanced skills in leading, influencing, and negotiating.
• Strong knowledge in the area of expertise.
• Collaborate and coordinate with higher-level outside resources.
• 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.
• Strong word processing, presentation, database, and spreadsheet application skills.
• Strong communication (both written and oral), facilitation, and presentation skills.
• Strong skill in working independently and effectively interacting with various levels.
• Advanced data trending and evaluation ability.
• Ability to evaluate compliance issues.
• Demonstrate the Client Values/Leadership Practices.

Contact: Send your resume with the job title to Flor Lopez at flopez@proqualitynet.com

Join our dynamic team where your skills make a difference! #JobOpportunity #QA #ScienceCareers