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.). This position is also responsible for assuring internal departmental procedures are in alignment with all Corporate and Regulatory requirements and initiating revisions to procedures, as well as serving as a technical resource for basic QA Release related issues. Serves as back up for team leader in their absence.
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.
Resolves major issues that are not defined by SOP.
Reviews and approves Certificates of Analysis and Certificates of Conformance for batch release.
Creates and revises export documentation as changes occur.
Completes change control action items as assigned.
Revises existing procedures as changes occur.
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 minimal supervision.
Completes all assigned training by target due dates as assigned by BIAH.
Completes on the job training for each assigned job task.
Cross trains on other job tasks within department.
Trains other individuals within the department on specific tasks.
Performs training of other individuals within department per assigned training plans.
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 audits as assigned by management.
High School Diploma AND 8 years of relevant experience OR Associate's degree from an accredited institution AND 6 years relevant experience OR Bachelor’s degree from an accredited institution, required.
Advanced written communication skills, attention to detail, ability to follow written procedures, SOPs, specifications and other documents, and ability to perform basic mathematical calculations are required.
NOTE: Relevant BIAH experience may be weighted more significantly.
This position requires ability to utilize computer programs such as Microsoft suite, SAP, IDEA for CON, Learning One Source and other relevant electronic applications.
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.
Additional requirements for this position include a basic understanding of QA Release processes within their area to assure departmental procedures are kept up to date with current practices and regulatory requirements, as well as leading/training others in basic job tasks and departmental improvements.
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
Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
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. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.