Job description

Requirements Education – Experience

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

Preferred requirements

• Educational background in Life Science and/or Engineering.

• 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

• Strong organizational skills, including ability to follow assignments through to completion.

• Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.

• Microsoft Office spreadsheet and application skills and presentation knowledge.

• Strong communication (both written and oral), facilitation and presentation skills. Fully Bilingual in English and Spanish.

• Validated skill in working independently and to optimally interact with all levels throughout the organization.

Description

SUMMARY

Perform one or more of the following duties and responsibilities in support of client’s Quality Assurance program under minimal supervision.

FUNCTIONS

- Review and approve product MPs.

- Approve process validation protocols and reports for manufacturing processes. - Request Quality on incident triage team.

- Approve Environmental Characterization reports.

- Release of 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.

EDUCATION/LICENSES

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

COMPETENCIES/SKILLS

- Project management skills.

- Strong organizational skills, including ability to follow assignments through to completion.

- Initiate and lead cross functional teams.

- Enhanced skills in leading, influencing and negotiating.

- Strong knowledge in 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 to effectively interact with various levels.

- Advanced data trending and evaluation.

- Ability to evaluate compliance issues.

- Demonstrate the client’s Values/Leadership Practices.

3rd Shift – Nonstandard

Job Type: Contract

Schedule:

• 8 hour shift
• Night shift

Work setting:

• In-person

Ability to commute/relocate:

• Juncos, PR 00777: Reliably commute or planning to relocate before starting work (Required)

Shift availability:

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

Work Location: In person

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