Location: Franklin,IN, USA
Overview
Berry Global Berry Global, headquartered in Evansville, Indiana, is committed to its mission of 'Always Advancing to Protect What's Important.' With $13 billion in revenue for fiscal year 2019 on a combined pro forma basis from operations, Berry is a leading global supplier of a broad range of innovative nonwoven, flexible, and rigid products used every day within consumer and industrial end markets. Berry operates over 290 manufacturing facilities worldwide, on six continents, and employs over 48,000 individuals.
At Berry, we pursue excellence in all that we do and are always advancing to improve the way we work along with the products and services we provide. Our culture fosters trust and partnerships through appreciation, acknowledgement, and inclusion. At Berry, we are continuously improving to support our mission and exemplify our values of partnerships, excellence, growth, and safety. To learn more about Berry, visit berryglobal.com.
Responsibilities
* Serve as plant's Validation Expert to ensure compliance to appropriate CFR's.
* Supports customer needs in coordination with plant management.
* Possesses and maintains an ongoing thorough knowledge of cGMP requirements and regulatory requirements.
* Maintain plant's Master Validation Plan and all supporting documents.
* Manage the plant's Qualification of Change system.
* Assist with complaint investigations and CAPA investigations.
* Participates in specification management: Assesses spec for capability, assembles data to support position, provide recommendation and coordinate plant input.
* Focus on Continuous Improvement efforts and drive improved quality efficiencies.
* Reviews and approves manufacturing processes, equipment, software changes to ensure that quality requirements are met.
* Assists with internal audits and supplier quality audits as needed.
* Manages continuous improvement activities regarding quality of all products as determined by manufacturing production events, heldware, scrap and customer complaints.
* Serve as plant resource for Lean Six Sigma initiatives.
* Contribute to evolving technology needs.
* Critical to have a high drive to root cause, countermeasure and resolve issues and problems found.
Qualifications
* 5-10 years experience in an FDA regulated industry preferred.
* Bachelors degree in an engineering discipline preferred.
* Deep level of experience with working in a team environment, high-paced and possesses the ability to partner with all functions within the organization.
* Must be able to demonstrate the ability to work with external customers and high level leaders.
* Demonstrated proficiency in Microsoft products along with ability to present
* Working knowledge of ISO quality standards
* Deep level of analytical and problem solving skills
Responsibilities - Serve as plant's Validation Expert to ensure compliance to appropriate CFR's. - Supports customer needs in coordination with plant management. - Possesses and maintains an ongoing thorough knowledge of cGMP requirements and regulatory requirements. - Maintain plant's Master Validation Plan and all supporting documents. - Manage the plant's Qualification of Change system. - Assist with complaint investigations and CAPA investigations. - Participates in specification management: Assesses spec for capability, assembles data to support position, provide recommendation and coordinate plant input. - Focus on Continuous Improvement efforts and drive improved quality efficiencies. - Reviews and approves manufacturing processes, equipment, software changes to ensure that quality requirements are met. - Assists with internal audits and supplier quality audits as needed. - Manages continuous improvement activities regarding quality of all products as determined by manufacturing production events, heldware, scrap and customer complaints. - Serve as plant resource for Lean Six Sigma initiatives. - Contribute to evolving technology needs. - Critical to have a high drive to root cause, countermeasure and resolve issues and problems found.