Become A Quality Specialist

* To perform this position successfully, an individual must be able to perform each essential duty and responsibility satisfactorily.
* The requirements listed below are representative of the knowledge, skill, and/or ability required.
* Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
* Responsible for coordinating HACCP programs at the facility.
* Responsible for performing daily record reviews to ensure all quality and regulatory requirements are met
* Handling all quality and food safety production holds, reconciliation and product release
* Assisting with all 3rdparty audits
* Data analysis and entry for statistical process control initiatives
* Leading root-cause analysis efforts and implementing corrective actions and preventative measures
* Completing special projects, duties and assignments as needed
* Leading facility personnel in continuous improvement initiatives
* Training quality assurance technicians on proper procedures
* Maintain systems for checking, validating and verifying process compliance
* Assisting with raw material and finished product analytical chemistry and microbiological testing
* Maintain, update, develop and implement quality policies and procedures
* Monitor food safety and food quality trends through data analysis and implement appropriate corrective actions and preventative measures
* Ensure efficient and accurate testing, reporting and monitoring of product safety and product quality
* Develop and deliver effective food safety and food quality training for facility team members
* Facilitate the development of analytical methods and sampling procedures
* Qualifications

* Applies current Good Manufacturing Principles (cGMP) in all areas of responsibility.
* Develops and administers GMP training.
* Assisting QA Manager with the Supplier Quality Management program.
* Monitoring internal and supplier audits through a Quality Management System (TrackWise).
* Helping QA Manager coordinate and execute the Internal Audit program.
* Assists with and follows-up on non-conformances, investigations, complaints, etc.
* Assures that issues are resolved in a timely manner and corrective actions/preventive actions (CAPA) are implemented and monitors effectiveness to prevent reoccurrence.
* Evaluates and develops techniques designed to maintain awareness of SOP’s, cGMP’s and clinical requirements.
* Extensively interacts with direct functional teams (Operations, Client Services, etc.) to resolve quality issues.
* Supports and assists on regulatory and client audits.
* Demonstrates and promotes the company vision

* Implement and maintain the business/site quality programs which align to the MPQ Business Quality Strategy at the plant level.
* Provide an effective interface between customers and the plant to ensure consistent high quality service to customers.
* Represent the “Voice of Customer” at the plant.
* Act as key plant interface to build or enhance relationships, services and flow of information between the plant and the customer, purchasing, supply chain, research, product stewardship and commercial organization related to the product quality / regulatory requirements related to the quality management system.
* Ensure that product returns and non-conforming product are appropriately managed to prevent unintended use, including disposition.
* Monitor the effectiveness of the quality management system and communicate to leadership improvement opportunities.
* For example, raw material quality and supplier assessments, etc.
* Generate and use quality data (customer complaints, plant metrics etc.) to enable cross functional partners to drive product quality improvements.
* Lead and participate in management of change reviews that potentially impact product quality (e.g. specification, train qualifications, plant equipment / systems, analytical testing, etc.).
* Ensure plant Operating Discipline system, procedures and guidelines meet quality system requirements, as appropriate (e.g.
* Good Manufacturing Practices, ISO 9001).
* Serve as element focal point for the quality requirements of the Operating Discipline Management System.
* Provide consultation on applicable material handling guidelines and quality requirements for External Manufacturing Operations Plan.
* Train and provide guidance to plant and other roles that impact product quality (e.g. lab, maintenance, logistics, etc.) on customer and product regulatory requirements, and the use of MPQ supporting tools and processes to achieve plant and business goals.
* Identify and lead improvement opportunities as determined through data analysis, customer audits, Six Sigma projects, and other quality-related programs.
* Host customer and other quality related external party visits and audits, in cooperation with Commercial and other functions.
* Lead / champion product quality problem solving efforts (i.e. Corrective Action Management Process, the Root Cause Investigation Process, including customer feedback, etc.).
* Establish and manage the plant quality system audit program, in conjunction with Business or Site strategies
* Conduct audits of plants, labs, terminals, warehouses, contract manufacturers, distributors, suppliers, customers, etc. to ensure customer needs are met.
* Leverage findings to drive continuous improvement.
* Lead or participate in the review of plant and cross functional projects having a potential impact on product quality.
* Work with business and plant personnel to introduce new products as part of the product qualification process.
* Lead or participate in business, site, and plant/department quality system networks,
* Ensure quality system tools (e.g. computer) are validated throughout the plant quality architecture

* Quality Review Responsibilities Includes but is not limited to the following:
* Reviews batch records for cGMP compliance, Good Documentation Practices and FDA regulatory requirements in order to approve/reject finished drug product for commercial distribution.
* Ensures all documents are present as issued by the Index Sheet.
* Ensures all blanks contain appropriate data.
* Verifies all accountability calculations.
* Verifies all Commodities, Active Pharmaceutical Ingredient (API), materials, and packaging components materials used are accurate and correct against on the Bill of Materials
* Verifies the solution hold times were met.
* Ensures that the temperature requirements and processing specifications are met throughout the manufacture/packing of the batch
* Reviews Line personnel records for correctness and accuracy.
* Verifies all Line clearances are properly documented.
* Verifies all quality control sampling and inspection has been met.
* Reviews all line interventions (aseptic).
* Ensures applicable Government Contracts have been met.
* Verifies all associated batch tickets and charts are present and accurate.
* Reports on batch deficiencies as noted during review that may delay batch release and consults with supervision or management on decisions for all issues.
* Plans for the completion of the batch documentation review in accordance within established schedules.
* Assures that all documents received in the batch release area reviewed for completeness and accuracy.
* Quality Final Release Responsibilities includes but is not limited to the following:
* Verifies all applicable subassemblies have been approved.
* Verifies all part of the batch record are present and have been audited.
* Verifies the Water for Injection is approved.
* Verifies any product restriction(s) have been resolved and are approved and removed.
* Verifies all deviations are thoroughly documented and approved and product has been correctly dispositioned.
* Completes applicable information on the Certificate of Analysis (CofA).
* Plans for the completion of the batch release in accordance within established schedules and performs the timely disposition of product lots release in the HK System.
* Ensures that all documents received in the batch release area reviewed for completeness, and dispositioned based on the review of the batch record data and lastly ensures the dispositioned batch record is archived in accordance with internal procedures and regulatory requirements (i.e. GMP, etc.).
* Additional Responsibilities:
* Assist with the closure of MDO packages and ensures the batch records are archived in accordance with internal procedures and regulatory requirements.
* Performs other related assignments and duties as required and assigned.
* Assist with internal, Corporate, third party and Federal/State audits, including FDA audits, as applicable.
* Supports and maintains an environment that fosters the Pfizer Own It culture within Batch Disposition and other departments

* Assume lead role in performing final batch disposition for affected products managed by Sanofi North America.
* Review associated batch documentation for compliance to cGMPs and Sanofi Standard Operating Procedures (SOPs).
* Communicate issues contributing to batch release delays in a timely manner to affected parties (Supply Chain, Customer Service, etc.).
* Maintain both internal and external customer service expectations with clear, concise communication and sense of urgency.
* Interact with manufacturing quality sites and internal functional units for resolution of quality issues or potential quality issues.
* Train and support other functional units on applicable quality systems and processes.
* Support product launch activities as required, with execution of product launch checklist, verification of product labeling, change control verification, etc.
* Assist in the development and improvement of various activities within the scope of the quality system as assigned