Job Description

SUMMARY

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

PREFERRED QUALIFICATIONS

-Experience with:

NPI, Change ControlS, FATs, Validation, and PPQs

EDUCATION

-Doctorate OR
-Masters + 2 years of directly related experience OR
-Bachelors + 4 years of directly related experience OR
-Associates + 8 years of directly related experience OR
-High school/GED + 10 years of directly related experience.

Preferred Backgrounds in Life Science and Engineering

SHIFT

Administrative Shift (8am-6pm, M-F)

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.

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 Company Values/Leadership Practices.

Job Types: Full-time, Contract

Pay: $40.00 - $42.00 per hour

Expected hours: 40 per week

Experience:

GMP: 3 years (Required) Change management: 3 years (Preferred)
Work Location: In person