Boehringer Ingelheim Associate III, QA Release in SAINT JOSEPH, Missouri
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
The basic purpose of this position is to perform sampling, inspection, documentation review and release of starting materials through finished goods for biological and pharmaceutical products. This position assures that all work is performed at a high level of accuracy, quality and that specifications are met prior to release according to all internal, Corporate and regulatory requirements (USDA, FDA, EU, etc.).
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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities
Prepares batch record documentation and performs review for compliance to Good Documentation Practices and against established SOPs/standards.
Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP.
Reviews and approves Certificates of Analysis and Certificates of Conformance for batch release.
Completes change control action items as assigned.
Initiates deviations in Quality electronic systems when non-conformances are detected during documentation review.
Performs follow-up on CAPAs for completion.
Performs movement transactions in SAP system of product as needed.
Performs usage decisions for batch release in SAP
Performs second check in SAP prior to batch release.
Actively participates on project teams as assigned by supervisor
Coordinates and leads projects with supervision.
Completes all assigned training by target due dates as assigned by BIVI.
Completes on the job training for each assigned job task.
Cross trains on other job tasks within department.
Assists with training other individuals within the department on specific tasks.
Following appropriate sampling plan, pulls correct number of samples for inspection of each incoming serial/lot.
Utilize electronic comparator (TVS) or manual tools for inspection of items (raw material, printed component, etc.) against standards/SOPs for conformance/acceptability.
Document results on inspection paperwork or electronically confirming acceptability of serial/lot.
Performs 2nd review/release approval of serials/lots.
Initiates non-conformance reports for serials/lots that do not meet requirements.
Performance of sampling activities for raw materials through finished goods to assure samples are representative, promptly submitted to internal laboratories for testing and the proper number of retention samples stored for each serial/lot.
Perform inspection of sampled items against standards for conformance/acceptability
Routine cleaning all sample retention areas,
Logs samples into appropriate tracking systems until destruction date
Inspection of samples during annual product review
Serves as a government approved APHIS sampler responsible for submission of Form 2020s and samples for cells, seeds, antigens and finished product samples to APHIS.
Participates in internal audits as assigned by management.
A minimum of a high school education plus five (5) years of relevant experience or an Associate's degree, from an accredited institution, plus three (3) year of relevant experience is required for this position.
Good written communication skills, including attention to detail, ability to follow written procedures, SOPs, specifications and other documents, and ability to perform basic mathematical calculations are required.
Some lifting up to 10 lbs. may be required for handling of samples. Primary work hours are first shift however, some overtime may be required due as business requirements change.
Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures.
Demonstrated high ethical and professional standards with all business contacts in order to maintain BIVI's excellent reputation in the community.
Desired Skills, Experience and Abilities:
- Work experience in USDA or regulated animal health industry is beneficial.
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
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA,Boehringer Ingelheim Vetmedica Inc. and Boehringer Ingelheim Fremont, Inc. is an equal opportunity employer. Minority/Female/Protected Veteran/Person with a Disability
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings.
Title: Associate III, QA Release
Location: Americas-US-MO-Saint Joseph
Requisition ID: 1815288