SR Quality Auditor

BoehringerPRD•Barceloneta, PR

About The Position

Provides Quality Assurance expertise, gives support and service to functional areas and to special activities/initiatives related to quality. Responsible of assuring that all established controls to certify drug products quality are implemented in the manufacturing and packaging operations. Accountable for assuring that production areas follow their SOP’s based upon his/her findings, and performs the final disposition of the in-process, raw materials, bulk products, finished goods and/or final assembled products. Provide support in compliance and regulatory aspects to other quality and production areas. 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 a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Requirements

Bachelor degree in Biology, Chemistry, Microbiology, Industrial Chemical Process, Engineering or Business Administration.
Minimum of two (2) years; experience in the pharmaceutical industry and/or manufacturing environment or related field.
Strong knowledge and understanding of cGMP’s for product release is essential.
Training skills including experience in the design, preparation, facilitation, evaluation and documentation of training.
Knowledge on statistical sampling plans is highly preferred, with experience in analytical, instrumentation, manufacturing practices and procedures.
Strong knowledge of and FDA mandated criteria is highly preferred.
Experienced using Office (Word, Excel, Power Point, Outlook) is required.
Experience working in a SAP environment is highly preferred.
ASQ Certification as Certified Quality Auditor (CQA) is preferred.
Communication skills in Spanish (proficient, verbal and written)
Technical English (read and write; understand verbal communication).
Demonstrated problem solving and decision making skills.
Effective verbal and written communications skills.
Excellent interpersonal skills.
Conflict management, influencing and negotiation skills.
Able to communicate with people at different levels across the organization.
Knowledge of federal regulation such as EMEA.

Nice To Haves

Knowledge on statistical sampling plans
Experience in analytical, instrumentation, manufacturing practices and procedures.
Strong knowledge of and FDA mandated criteria
Experience working in a SAP environment
ASQ Certification as Certified Quality Auditor (CQA)

Responsibilities

Audits the manufacturing, formulation, filling and/or packaging process documentation to assure adherence to cGMP’s, company policies, guidelines and procedures (SOPs).
Provides evidence for the product disposition if required.
Performs final disposition, change status of raw materials, intermediates and finished material in the inventory system and physical in adherence to cGMP’s, company policies and procedures according to the product release lead-times.
Assures that all questionable material is quarantined and/or rejected.
Informs QO management of the status of operations and reports unusual situations and/or problems.
Develops and implements quality control procedures, reporting forms and any other necessary documentation required to minimize quality risk and cost to production, QO laboratory, warehouse, dispensing, and/or product distribution.
Maintains direct communication with other departments, such as Production, Procurement, Engineering, Logistics, among others.
Provides support to regulatory and compliance issues, including complaint investigations, annual review preparation, supplier audits, regulatory documents requests among others.
Responsible to obtain and report site QA metrics according to schedule.
Performs special projects as required and/or as assigned, as well as participates in meetings related with area of responsibility.
Complies with all environmental guidelines, procedures, training, practices, permit conditions, and internal notification of any environmental events.
Provides support in the training process to new auditors on departmental practices and procedures.
Acts as a key user for SAP Quality Management, if required.
Act as Quality representative in site projects such as new product introductions/site transfer, providing guidance to all activities required to assure compliance with cGMP’s.
Support completion of Change Control documents.
Perform evaluation and follow up of deviations.
Actively participate in events discussions to assist in a timely resolution and identification of proper corrective and preventive actions (CAPA).
Participate in site Inspection Readiness program performing walkthroughs and internal audits.
Act as Subject Matter Expert for a Quality System, if assigned.
Provides support during regulatory or corporate audits by coordination and/or attendance of audit assurance documentation completeness, review and availability.
Will realize other assignments related with Quality Operations responsibilities at the direction of the Quality Assurance Head/Supervisor.
Work under minimal supervision, thorough knowledge of plant operations and ability to communicate to all levels of management.