Job Description

Position Summary

The Quality Assurance Specialist I-II is responsible for ensuring compliance with company and cGMP standards. Responsibilities of this role include GLP quality inspection, cGMP record review and approvals, and QMS documentation approvals. The Quality Specialist I-II role will work directly with laboratory analysts and management ensuring review and processing of documents in accordance with FDA and ICH guidelines.

Essential Functions

• Review and approval of analytical documentation including method transfer protocols, analytical data, reports, and COA/ COR for In-Process, Release, and Stability.
• Audits system trails in the Empower software, UV software and GC software suites.
• Perform GLP phase inspections in support of In-Vitro Testing and Bioanalytical validations and regulated study protocol and report reviews.
• Quality Assurance review and approval of instrument/equipment calibration documentation, investigations, deviations, CAPAs and change controls.
• Support electronic review and archival of quality documentation, including but not limited to, SOPs, Specifications, Equipment Qualification/Validation, Methods and Protocols.
• Quality Assurance review and approval of laboratory documentation.
• Knowledge and understanding of Analytical Testing Methods, Good Laboratory Practices, and Good Documentation Practices.
• Demonstrates professionalism and an understanding of quality in a regulated industry.
• Other duties as assigned.

Supervisory responsibilities

• None

Key Relationships (examples: Depts or Individual positions that this position will be working closely with):

• Quality Control
• Analytical R&D
• In Vitro Testing and Bioanalytical

Travel requirements

• N/A

Education and Experience

• B.A. or B.S. in a scientific discipline.
• 2 - 3 years' experience in a Quality Assurance / compliance role in a GMP/GLP-compliant pharmaceutical, analytical environment, preferred.
• 1+ years of analytical laboratory experience required.

Knowledge, Skills, and Abilities

• Strong organizational skills and ability to manage multiple tasks at one time.
• Proven ability to collaborate with technical staff with minimal management.
• Able to multi-task productively, applying time management processes and procedures effectively.
• Demonstrates risk-based decision making.
• Strong communication skills, both written and oral.

Physical Demands and Work Environment

While performing the duties of this job, there may be certain physical demands required for the position.

• Requires frequent standing, walking, & sitting
• Requires occasional carrying, lifting, pushing, & pulling under 20 LBS
• Requires occasional bending, twisting, reaching, & gripping
• Requires constant seeing & hearing

Other Duties

You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.

Limitations and Disclaimer

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.

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