Overview
Quality Control I-Process Inspector for Manufacturing Floor Jobs in Keene, NH at Samson Manufacturing
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies’ success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim’s high regard for our employees.
The Senior Principal Specialist QA is responsible for the development, implementation, and maintenance of quality systems, procedures and training at the GI site to ensure the integrity and compliance of GI outputs intended for regulatory submissions. This role oversees the process for implementing new product registrations or extended registrations for BI AH as well as ensures that the site is ready for GxP regulatory inspections. The incumbent serves as subject matter expert in quality standard (GxPs).
Duties & Responsibilities
Manages Deviations, Investigations and CAPA Process, and change controls opened and their potential impact.
Leads working groups aiming at harmonizing and improving QS processes and/or serve as local GIQA project representative on Q projects.
Local Inspections and Audits:
Leads in the organization, execution and follow up of GxP inspections and audits. Inspections and audits may include internal audits of GI facilities and systems for compliance with international regulatory directives and corporate, divisional and departmental policies and procedures.
Performs follow-up of CAPA plan.
Leads and conducts third party audits for local suppliers.
Where applicable, leads and conducts in-process GCP/GLP audits (e.g., critical phase inspections, investigator site audits or similar) and prepares reports within defined timelines.
Documentation:
Provides QA oversight for local quality system documents.
Approves as QA the necessary procedures in place to cover GI GxP activities (e.g., SOP, specifications).
Ensures compliance of facilities and equipment by reviewing the appropriate documentation (e.g., validation, logbook, qualification report, …).
Training:
Conducts and provides training to GI personnel to ensure knowledge of regulations, guidelines, and standard operating procedures. If required, also conducts other quality trainings as per identified needs.
Proactively identifies additional training needs based on audit observations.
Process Improvement:
Identifies opportunities for improvements and gains approval for/implements quality improvements.
Provides timely and accurate reporting of appropriate measures of quality performance to GI management (e.g., KPIs, QMRs).
Requirements
Bachelor’s degree required with major focus on Biology, Chemistry, Pharmaceutics, Veterinary or Quality Management. Master’s degree preferred.
Eight (8) years operational experience in a pharmaceutical / vaccine quality environment.
Experience conducting audits in the pharmaceutical, biological, or equivalent industry.
Experience in the pharmaceutical, biological, or equivalent industry.
Rigor, autonomy, organization in the work, ability to work in a team, good interpersonal skills, proactivity, strength of conviction.
Good understanding in working in cross-functional projects and environments.
Excellent communication skills in local language (spoken and written), good communication skills in English.
Good knowledge in GxP.
Experience in quality assurance and quality management.
Experience in leading internal audits.
Ability to work in a project team environment.
Excellent verbal and written communication skills.
Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook, PowerPoint).
Eligibility Requirements :
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.
Desired Skills, Experience and Abilities
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Title: Quality Control I-Process Inspector for Manufacturing Floor
Company: Samson Manufacturing
Location: Keene, NH
