Specialist Quality Assurance

*Job Summary*

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

*EDUCATION/LICENSES*
-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

*Preferred Educational Background: Science or Engineering Background*

*Preferred Qualifications*

* Experienced quality assurance specialist.
* Commissioning and Qualification of Equipment/Systems/Facilities
* Auditing Equipment/Facilities/Utilities of Qualification Protocols and execution
* Revision and approvals of technical documents like URS, Design, Report of technical data.
* Deep knowledge of quality assurance terminology, methods, and tools
* Knowledge on Veeva, CDOCS applications.
* Pharmaceutical environment experience
* Spoken languages: Spanish and English

*Shift: Administrative Shift (8am-5pm)*

*Responsibilities*

* 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 - $43.00 per hour

Schedule:
* 8 hour shift
* Day shift
* Monday to Friday
* Overtime

Work Location: In person