Quality Assurance Specialist II - Validation

• Provide Quality review and approval of various validation/qualification and documentation, including, but not limited to, LIMs, calibration, process, laboratory, CSV, and cleaning for conformance to regulations, SOPs, specifications and other applicable acceptance criteria with management oversight.

• Provide Quality review and approval of equipment records and Work Order documentation within the Blue Mountain Regulatory Asset Manager (BMRAM) for conformance to regulations, SOPs, specifications and other applicable acceptance criteria with management oversight.

• Provide Quality review and edits (as appropriate) to Standard Operating Procedures to ensure up to date with regulatory and company standards.

• Provide Quality support for the execution of various validation/qualification documentation, including, but not limited to LIMs, process, laboratory, CSV, and cleaning.

• Contribute to the generation and review of required Quality documentation (Standard Operating Procedures, protocols, change controls, etc.) to support quality validation activities and programs as assigned by Management.

• Creates Quality metrics as assigned.

• Provide adequate reporting and communication of projects to project manager, stakeholders and department manager.

• Responsible for accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks

• Assists in deviation investigations.

• Collaborates with internal departments on strategy and implementation of quality principles and regulation requirements

• Identifies and escalates critical quality issues appropriately to senior management.

Requirements

Description

Education/Training

Bachelors Degree in Science/Engineering or related field required

Experience

3+ years of related quality and/or validation experience in a cGMP environment.

Strong knowledge and experience in the cGxPs, with a focus on Laboratory and Manufacturing Practices.

Experience in root cause analysis, risk assessment and investigation tools/techniques.

Skills/Abilities

Strong organizational, analytical, and time management skills.

Ability to work well in a team environment with a positive attitude that is willing to assist other areas of the organization.

Excellent verbal and written communication skills as well as strong focus and attention to detail.

Detail orientated and ability to work in a fast-paced environment with the ability to handle multitude of projects with overlapping schedules.

Knowledge and understanding of validation lifecycle.

Strong Mechanical aptitude and strong technical writing skills.

Experience with Lab equipment and CSV qualification methodologies.

Ability to read/interpret P&ID drawings.