Specialist QA 2995024

Title: Specialist QA 29995024 (Biotechnology Industry)

Location: Open to locals in Puerto Rico (Hybrid/Remote allowed, but onsite preferred)

Shift: Administrative Shift

Positions Available: 1

Duration: Approximately 11 months

SUMMARY:

Perform a variety of duties and responsibilities in support of our client's Quality Assurance program under minimal supervision.

Educational and Experience Requirements:

• Doctorate degree or Master's degree with 3 years of directly related experience,
• Bachelor's degree with 5 years of directly related experience,
• Associate's degree with 10 years of directly related experience,
• High school diploma / GED with 12 years of directly related experience.

Preferred Qualifications:

• Experience in quality assurance for deviations, preventive maintenance, job plans, change control, and FMEA.

FUNCTIONS:

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Request Quality support for incident triage teams.
• Approve Environmental Characterization reports.
• Release sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI (New Product Introduction) teams.
• Lead investigations.
• Lead site audits.
• Own site quality program procedures.
• Serve as designee for the QA manager on the 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 (Corrective and Preventive Actions) records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment.

COMPETENCIES/SKILLS:

• Strong project management skills.
• Excellent organizational skills, with the ability to complete assignments.
• Ability to initiate and lead cross-functional teams.
• Advanced skills in leading, influencing, and negotiating.
• In-depth knowledge in area of expertise.
• Collaborate and coordinate with external higher-level resources.
• Strong knowledge of processes involved in manufacturing, distribution, QA, QAL, validation, and process development.
• Ability to interact with regulatory agencies.
• Strong proficiency in word processing, presentation, database, and spreadsheet applications.
• Strong communication skills (written and oral), including facilitation and presentation skills.
• Ability to work independently and interact with various levels of personnel.
• Advanced data trending and evaluation skills.
• Ability to evaluate compliance issues.
• Demonstrate Our client Values and Leadership Practices.

Interested candidates are invited to apply for this exciting opportunity inside the job description with an updated resume.