Job description

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:

• Approve process validation protocols and reports for manufacturing processes. - Request Quality on incident triage team.
• Review and approve product MPs.
• Perform sampling plans for all manufactured products
• Perform batch record review
• Perform SAP transactions
• Perform Trackwise system queries, deviations
• Participate in triage process
• Perform oversight of the process and procedures/GMP tasks
• Compliance review of batch record elements (e.g., MPs, MSRs) and identification of discrepancies
• Participate in internal plant audits
• Work with operations to resolve basic compliance discrepancies
• Approve NC investigations and CAPA records.
• Lead site audits.
• Review Risk Assessments.
• Support Automation activities.
• Support facilities and environmental programs.
• Approve change controls.

Qualifications:

• Bachelor's degree and 5 years of directly related experience in Life sciences or Engineering.
• Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.
• 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.
• Ability to evaluate compliance issues.
• Experience with processes involved in manufacturing and QA.
• 3rd Shift availability (5:00pm to 5:30am)

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Job Types: Full-time, Temporary

Experience level:

• 5 years

Schedule:

• 12 hour shift
• Night shift

Work setting:

• In-person

Ability to commute/relocate:

• Juncos, PR: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• Manufacturing: 5 years (Preferred)
• Quality Assurance: 5 years (Preferred)

Shift availability:

• Overnight Shift (Required)
• Night Shift (Required)

Work Location: One location

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