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:

• Perform sampling plans for all manufactured products
• Perform batch record review
• Perform SAP transactions.
• Perform Trackwise system queries, deviations
• Lead investigations and site audits.
• Review Risk Assessments.
• Support Automation activities.
• Support facilities and environmental programs..
• Review and approve EMS/BMS alarms.
• Approve NC investigations, CAPA records and change controls.
• Provide lot disposition and authorize lots for shipment.

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.
• 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.
• Non-Standard Shift availability (5:00pm to 5:30am)

Job Types: Contract, Temporary

Experience level:

• 5 years

Schedule:

• 12 hour shift

Work setting:

• In-person

Ability to commute/relocate:

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

Experience:

• QA/QC: 1 year (Required)

Shift availability:

• Night Shift (Preferred)
• Overnight Shift (Preferred)

Work Location: In person

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