The incumbent provides support to new product registrations. Implements procedures to ensure the integrity of all research output intended for regulatory submissions.
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:
Provides QA support to new product registrations for R&D Audit assigned efficacy, safety, validation, bioanalytical for compliance with US and EU regulatory directives (i.e. FDA, EPA OECD).
Ensure that studies are conducted and the data collected in compliance with appropriate guidelines, protocol, Standard Operating Procedures and /or other governing factors.
Assist in conducting audits of R&D departments for compliance with regulatory directives and corporate, divisional and departmental policies and procedures and communication issues relative to clinical studies.
Issue timely and accurate audit reports that communicate what was audited and any observations on noncompliance issues observed.
Review R&D departmental SOPs for compliance with regulatory directives and Merial quality standards.
Conduct audits and inspections of Merial and contract facilities to ensure adherence to Merial quality requirements.
Serve on Pharma R&D Project Teams or Local Process/Project Teams.
Provide GXP training across sites. Facilitate regulatory inspections, on and off-site.
B.S./B.A degree in the life sciences is required.
Prior 5-7 years experience conducting audits in the pharmaceutical, biological or equivalent industry is required.
Ability to work in a project team environment.
Strong oral and written communication skills and interpersonal skills are required.
Knowledge of USDA, EPA, FDA and /or OECD regulations and guidelines.
Fluency with MS Word and Excel software is recommended.
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 one of the world's top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. 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. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighbourhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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 verifications and drug screenings