Job Description

Job Description

Job Description

Description:

SHINE Technologies is seeking a Quality Improvement Specialist who will support the quality management team in executing daily, routine tasks related to data management and executed documentation. The position will also support short- and long-term continuous improvement initiatives related to the QMS and LIMS systems as well as other quality programs. The employee will work cross functionally within SHINE Therapeutics to support multiple teams to lead and implement quality assurance methods and procedures as directed by the Quality Management.

The base salary range for this position is $69,000 - $90,000 per year plus a comprehensive compensation package. Our salary ranges are determined by role, level, and location.

Duties and Responsibilities:

Specific duties and responsibilities include, but are not limited to:

• Act as administrator for Quality Management System and Laboratory Information Management System for general maintenance and continuous improvement initiatives.
• Assist with drafting or executing various quality documentation including but not limited to SOPs, Work Instructions, validations, specifications, etc.
• Perform and support investigation and deviation programs including evaluation of root cause and impact analysis and provide corrective action.
• Assist in data review of all data generated within the Quality Unit.
• Lead data trending efforts for all data generated within the Quality Unit, including environmental monitoring (e.g. production areas, water, compressed air, etc.) and finished product analysis (e.g. release and stability testing) and provide recommendation for corrective actions to negative data trends.
• Review and approve executed method validation documentation.
• Perform reviews of facility wide logbooks, including periodic and final close out, to confirm all requirements of tasks are completed successfully.
• Ensure compliance with quality programs and initiatives throughout all departments within the commercial manufacturing facility.
• Perform internal audits to ensure compliance with SHINE procedures and all regulatory statutes, utilizing risk management to determine areas to audit.
• Assist with compiling and managing documentation related to various regulatory submissions.
• Perform other tasks as assigned by Quality Unit management.

• Bachelor of Science degree in scientific discipline including biology, chemistry, engineering, radiochemistry, or physics.
• Previous experience of 3-5 years in pharmaceutical or medical device company in a quality or regulatory related role is required.
• Ability to work across multiple functional groups and provide effective communication of ideas to influence management decisions.
• Willingness to be hands on with tasks and provide pragmatic approaches to continuous improvement initiatives.
• Maintain safety and quality mindset utilizing methodical and pragmatic suggestions while developing continuous improvement initiatives.
• Prioritize tasks based on management direction with adherence to required schedules.
• Provide open communication related to tasks and project status to direct supervisor and across multiple teams.

Eligibility for employment is conditioned on the applicant’s ability to qualify for access to information subject to U.S. Export Controls. Additionally, applicant’s eligibility may be conditioned based upon meeting the Nuclear Regulatory Commission requirements for access to Safeguards Information, which typically requires a pre-employment drug screen, fingerprinting and criminal background check.

SHINE values diversity in all its forms as a critical component of innovation, which is fundamental to our success. Every member of the SHINE community benefits from the talents and experiences of our peers, from the mutual respect we exercise, and from the responsibility we take for our actions.

SHINE Technologies is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

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