Quality Assurance Manager 9/2/2016
JOB DESCRIPTIONAPPLY OPPORTUNITY: Quality Assurance Manager
REPORTS TO: VP Quality and Plant Manager
LOCATION: Dallas, Texas
The company is a privately held, rapidly growing provider of contract packaging services. With proven experience providing contract packaging solutions to some of the world largest and best known CPG companies, the company is constantly developing innovative products and service offerings for their customer's packaging needs. The company currently has production and distribution space through six facilities based in the Midwest, Southeast and Southwestern U.S. The company is committed to rapid growth both domestically and internationally while continuing to provide innovative, quality and, cost effective solutions to their customers.
The Quality Assurance Manager is responsible for managing the daily functions of the site Quality Assurance department. In conjunction with corporate Quality Assurance ensure the facilities SOPs are up to date according to company procedures and government regulations, and then implement procedures and action plants that enable these SOPs and procedures are being adhered to. Manage the QA release process for the mixing center that ensures only acceptable components and finished product is released per government regulations and customer requirements. Monitor, document and report the performance of the qualitysystem, report facilities status to both corporate QA and to the site's management team. Ensure all necessary procedures are in place to enable product to be made to customer specification and that the site is in compliance with regulations (Federal, State, Local, Customer, and 3rd party). Lead the site's SIP program and assist with all process improvement effort. Manage the facilities validation procedure, process change process along with the internal CAPA process. Ensure that procedures are implemented to enable company to properly control appropriate documents such as SOPs, change control forms, audit records, and product release forms. Key accountabilities shall include, but not be limited to, the following:
* Ownership and management of the facility SIP Program
* Oversee the approval process for the release of components/materials and finished product per regulatory and customer requirements.
* Ensure systems are utilized to properly control defective materials until QA approval to release, return to supplier or dispositioned according to regulations.
* Reports non-conformance of product and materials to company's procurement team for corrective action.
* Ensure process change procedures are documented and approved by quality assurance prior to implementation
* Review and approve validation protocols and qualification reports prior to implementation.
* Ensure customer requirements are met and documented with proper auditing and all customer approvals and releases are controlled per company procedures.
* Management of the facility CAPA program (corrective action, preventive action. Initiate and facilitate corrective and preventative measures to ensure processes are in control and consistently produce product that meets or exceeds customer expectations.
* Communicate internally and to customers on issues requiring resolution as it pertains to quality procedures.
* Primary site contact for customer & regulatory audits
* Ensure the Quality department is properly staffed, trained, and motivated to meet company objectives and meet/ exceed customer requirements. 5 direct reports.
* Ensure SOPs and other documentation relating to departmental functions are accurate. Create/ revise procedures as needed.
* Approve/ issue annual performance evaluations.
* Set goals for the department and establish methods to obtain those goals.
* Track and report on departmental metrics.
* Work in conjunction with all members of the management team to foster a team environment and help with ensuring the overall success of the company.
DESIRED SKILLS & EXPERIENCE:
* BS/ BA/ Master's degree or comparable experience
* Experience with managing a quality department that operated within a regulated manufacturing or packaging environment (FDA, OSHA, cGMP, etc.)
* Previous experience managing a multiple shift operation Excellent analytical and problem solving skills
* Experience in cost savings beneficial
* Excellent interpersonal skills
* Excellent oral and written communication skills. Fluency in English required. Proficiency in Spanish a plus.
* Knowledgeable in principals of CFR 210 & 2111, along with total quality management, Lean Six Sigma, Continuous Improvement
* The chosen candidate will be expected to travel approximately 10-15%.