Specialist, Quality Assurance

This role will support GxP processes and assist operations in various capacities, including providing support for the following programs: Inspection Readiness, Self-Inspections, Quality Management System, Real-Time Production support, Line Clearance and Oversight, and Validation/Qualification activities.
This is a 2nd Shift position, requiring a long-term dedication to the shift. Hours are 2:30pm-10:00pm Monday thru Friday.
Typical Accountabilities

Support specific Quality Operations processes within assigned area:

• External Audit Readiness - support the preparation activities for internal and external inspections, including FDA, EMA, and other regulatory bodies. Support inspection readiness plans and conduct routine mock inspections to ensure preparedness. Assist in audits, inspections, and response process as applicable.

• Self Inspection Program – Assist in developing and performing the site’s annual self inspection plan to ensure Quality standards are upheld in advance of external regulatory audits.

• Batch Record Review/Approval – act as the final signatory on production records ensuring data integrity and right first time execution of the production records.  Partner with operations teams to remediate errors and improve execution of production standards.

• Line Clearance and Oversight – conduct daily walk through inspections (GENBA) of the Aseptic Filling, Pack Operations, and supporting areas throughout the facility to confirm GMP processes and standards are being followed. 

• Validation Review/Approval – support real time review of validation activities and final approval of validation packages to ensure data integrity principles and quality by design

• Work cross functionally with other Quality teams to support:

  • Acceptable Quality Limit (AQL) Inspections

  • Deviation Investigations and CAPA Planning

  • Quality Risk Management

  • Product Complaint Investigations

  • Change Control Planning and Execution

  • GDP Data Review and Trending
     

• Partner and support operations functions related to Quality standards and regulatory expectations.

• Provide guidance and support to cross-functional teams, in risk management, compliance and sharing valuable observations and takeaways.

• Lead and implement simplification and improvement initiatives in collaboration with other quality assurance colleagues.

• Help update training content and support training sessions passionate about quality standards, compliance, and inspection preparation for staff at various levels.

• Stay continually updated with current industry practices and changes in regulatory guidelines to ensure the organization remains compliant.

Essential:

• Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, or Chemistry 

• 3 years’ experience within pharmaceutical manufacturing and quality 

• Strong orientation for continuous improvement and process streamlining and optimization.

• Experience applying Lean principles and delivering change initiatives within a structured framework.

• Self-motivated individual that works independently.

• Effective communication and interpersonal skills are required. 

Desirable:

• Project management experience 

• Lean manufacturing experience 

• Some experience in business process/ quality system management.

• Knowledge of/ experience with newer digital tools and technologies related to quality systems management.  

• Regulatory and compliance experience with an organization such as FDA, MHRA, EMA, ANVISA, HC, and KFDA.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.