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Specialist / Principal Specialist / Sr. Principal Specialist Manufacturing Compliance

Company name
Boehringer Ingelheim

Location
Fremont, CA

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Job Description
Description:\r\rSpecialist / Principal Specialist / Sr. Principal Specialist, Manufacturing Compliance\r\rDescription\\:\r\rUnder minimal\rsupervision, this position is responsible to manage projects, lead teams to\rinvestigate thorough investigations, and facilitate effective meetings. \rThis role is responsible to lead the following aspects within Manufacturing\\:\r\r\r Deviation investigation\r and/Corrective and Preventative Actions (CAPA) completion,\r Change control ownership\r Project management\r Trend key performance metrics\r Participate in\r audits/inspection\r\r\rThis position is also\rresponsible to complete specific projects and activities to keep Manufacturing\rprepared for audits and inspections. \r\r\r\rAs an employee of\rBoehringer Ingelheim, you will actively contribute to the discovery,\rdevelopment and delivery of our products to our patients and customers. Our\rglobal presence provides opportunity for all employees to collaborate\rinternationally, offering visibility and opportunity to directly contribute to\rthe companies' success. We realize that our strength and competitive advantage\rlie with our people. We support our employees in a number of ways to foster a\rhealthy working environment, meaningful work, diversity and inclusion,\rmobility, networking and work-life balance. Our competitive compensation and\rbenefit programs reflect Boehringer Ingelheim's high regard for our employees.\r\r\r\rDuties & Responsibilities\\:\r\r\r New Product Introduction\\:\r Supports the introduction of\r new product introduction activities and ensures procedural requirements\r are met.\r Leads team to complete\r assessments on time, determine deliverables prior to introduction, and own\r the over-arching change control. Ensures deliverables meet procedural\r requirements.\r Investigations and corrective\r actions\\:\r Thoroughly investigates\r deviation events utilizing root cause analysis techniques.  Utilizes\r technical writing strategies to ensure content is clear, concise, and\r complete.  Leads team to evaluate pertinent aspects involved in\r determining deviation scope, impact, and to perform necessary evaluations\r to support conclusions.  Ensures corrections are initiated to address\r root cause and contributing causes discovered during investigation.\r Inspection Preparation and\r Readiness\r Responsible for maintaining\r inspection readiness within Manufacturing in the following ways\\: \r \r Generates play books for\r complex deviations, CAPA, and change controls.\r Identify, propose, and\r executes compliance process and procedural changes to reduce deviations.\r Implements corrective actions.\r Provides hands-on training /\r guidance on MFG compliance, and reinforces cGMPs to increase quality and\r compliance knowledge throughout MFG organization.\r Leads area walk throughs for\r housekeeping\r \r Key Performance Indicators\r Independently analyze data\r relative to defined KPI.  Make recommendations for improvement based\r upon the data gathered.\r\r\rRequirements (Specialist\rManufacturing Compliance)\\:\r\r\r Bachelors’ Degree with > 2\r years of related professional experience\r Experience leading projects is\r required\r Broad technical knowledge of\r cGMP systems and experience with leading investigations, writing \r deviation reports, owning change controls, and corrective actions\r Understands manufacturing\r processes\r Runs effective meetings\r Skilled at creating and\r delivering presentations\r Technical writing\r Provides training and guidance\r to others\r\r\rDesired Experience,\rSkills and Abilities\\:\r\r\r Experience leading cross\r functional teams\r\r\rRequirements (Principal Specialist\rManufacturing Compliance)\\:\r\r\r Bachelors’ Degree with 4 - 6\r years of related professional experience\r Experience leading projects is\r required\r Broad technical knowledge of\r cGMP systems and experience with leading investigations, writing \r deviation reports, owning change controls, and corrective actions\r Understands manufacturing\r processes\r Runs effective meetings\r Skilled at creating and\r delivering presentations\r Technical writing\r Provides training and guidance\r to others\r\r\rDesired Experience,\rSkills and Abilities\\:\r\r\r Experience leading cross\r functional teams\r\r\rRequirements (Sr.\rPrincipal Specialist Manufacturing Compliance)\\:\r\r\r Bachelors’ Degree with 6 - 8\r years of related professional experience or more\r Experience leading projects is\r required\r Broad technical knowledge of\r cGMP systems and experience with leading investigations, writing \r deviation reports, owning change controls, and corrective actions\r Understands manufacturing\r processes\r Runs effective meetings\r Skilled at creating and\r delivering presentations\r Technical writing\r Provides training and guidance\r to others\r\r\rDesired Experience,\rSkills and Abilities\\:\r\r\r Experience leading cross\r functional teams\r\r\rEligibility\rRequirements\\:\r\r\r Must be legally authorized to\r work in the United States without restriction.\r Must be willing to take a drug\r test and post-offer physical (if required)\r Must be 18 years of age or\r older\r\r\rOur Culture\\:\r\rBoehringer Ingelheim\ris one\rof the world’s top 20 pharmaceutical companies and operates globally with\rapproximately 50,000 employees.  Since our founding in 1885, the company\rhas remained family-owned and today we are committed to creating value through\rinnovation in three business areas including human pharmaceuticals, animal\rhealth and biopharmaceutical contract manufacturing.  Since we are\rprivately held, we have the ability to take an innovative, long-term\rview.   Our focus is on scientific discoveries and the introduction\rof truly novel medicines that improve lives and provide valuable services and\rsupport to patients and their families.  Employees are challenged to take\rinitiative and achieve outstanding results. Ultimately, our culture and drive\rallows us to maintain one of the highest levels of excellence in our industry.\rWe are also deeply committed to our communities and our employees create and\rengage in programs that strengthen the neighborhoods where we live and\rwork.  Boehringer Ingelheim,\rincluding Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA,\rBoehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and\rBoehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative\raction employer committed to a culturally diverse workforce.  All\rqualified applicants will receive consideration for employment without regard\rto race; color; creed; religion; national origin; age; ancestry; nationality;\rmarital, domestic partnership or civil union status; sex, gender identity or\rexpression; affectional or sexual orientation; disability; veteran or military\rstatus, including protected veteran status; domestic violence victim status;\ratypical cellular or blood trait; genetic information (including the refusal to\rsubmit to genetic testing) or any other characteristic protected by law.\r\r\r\rBoehringer Ingelheim is\rfirmly committed to ensuring a safe, healthy, productive and efficient work\renvironment for our employees, partners and customers. As part of that\rcommitment, Boehringer Ingelheim conducts pre-employment verifications and drug\rscreenings.\r\r\r*LI-SF1\r*I-SF1

Company info

Boehringer Ingelheim
Website : http://www.boehringer-ingelheim.com

Company Profile
Boehringer Ingelheim is a global group of companies embracing many cultures and diverse societies. Learn more about the financial highlights, the corporate vision, the organisation, the Board of Managing Directors and the company's history as well as our engagement for scientific, cultural and environmental purposes.

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