Quality Assurance Lead - Finishing (3rd Shift)

Simtra BioPharma Solutions•Bloomington, IN

13d

About The Position

The Quality Assurance Lead – Packaging is a member of the Quality Assurance Leadership Team and reports directly to the Quality Manager. The role provides direct support to 3rd Shift Quality Assurance Associates and Manufacturing – Packaging to ensure finished products meet required specifications. The Lead supervises and directs QA Associates who provide quality oversight in the Inspection and Packaging complex, and makes decisions to ensure compliance with regulatory requirements, guidelines, and Simtra Standard Operating Procedures. The position supports and drives quality operations on the production floor and communicates with production team members, management, and support departments. It promotes teamwork, productivity, safety, and the quality attributes of identity, strength, purity, and quality (SISPQ) in finished products. The schedule is Monday through Friday, 10:45 p.m. to 6:45 a.m.

Requirements

Bachelor’s degree, preferably in a science discipline, with at least 2 years of Pharmaceutical Quality/Manufacturing or other GXP-regulated industry experience; or an Associate’s degree with at least 3 years of such experience; or no degree with at least 5 years of such experience.
At least 2 years in a leadership role.
Good interpersonal communication skills.
Working knowledge of FDA regulations and application of Good Documentation Practices and Good Manufacturing Practices.
Strong technical writing skills.
Strong problem-solving skills.
Computer proficiency in Microsoft Word, Excel, and Outlook, and ability to use enterprise software such as D365, Veeva, or ROBAR.
Ability to perform physical tasks including bending, twisting, kneeling, and stooping; sit and stand for extended periods; wear appropriate personal protective equipment; and use hands and fingers to manipulate office equipment.
Ability to work overtime, including nights, weekends, and holidays, as duties may require.

Nice To Haves

Knowledge of inspection, labeling, and packaging equipment and processes.

Responsibilities

Lead and support 3rd Shift QA Associates and Manufacturing – Packaging to ensure finished products meet specifications.
Supervise and lead QA Associates providing oversight in the Inspection and Packaging complex.
Provide decision-making and oversight to ensure compliance with regulatory agency requirements, guidelines, and Simtra Standard Operating Procedures.
Handle multiple projects and demonstrate team leadership, empowerment, task completion, decision-making, problem-solving, and deviation management.
Become a subject matter expert on applicable Inspection and Packaging Quality procedures and ensure department procedures align with global and regulatory standards.
Plan and schedule QA Inspector work for quality inspections and label control.
Interview, hire, coach, and develop staff; provide guidance and leadership; and conduct performance reviews, set objectives, and create development plans for direct reports.
Achieve quality objectives aligned with site goals accurately, efficiently, and on time; ensure department business and timeliness requirements are met or exceeded.
Participate in or lead process and product improvement projects, focus groups, design of experiments, validations, methodology development and improvement, data generation, report development, and presentations.
Maintain the Inspection and Packaging complex in an audit-ready state and stay current with regulatory and client requirements.
Assist with and approve validations, audits, and assessments; author, review, or approve deviations, CAPAs, TSSs, Bills of Materials, Finishing Specification Sheets, and Line Records.
Manage change-control activities and documentation, including validation change control, work orders, and holds.
Track and trend Quality data for review and reporting.
Work with Production Supervision, Engineering, and Maintenance to ensure appropriate resolutions to equipment issues arising during batch processing.