Christopher Salyer Email & Phone Number

Bloomdale, Oh, Us

Bluffton, Ohio, Us

Manages the Quality Assurance staff; Contributes and prepares the Quality Assurance portion of the Business Plan; Monitors APQP activities of the Quality Assurance department and ensures compliance to SRK-OH and Customer requirements; Ensures compliance to customer guidelines and expectations; Works with customers and suppliers to resolve quality concerns; Manages internal and external reporting; Manages Internal Quality Assurance activities including QA Lab Testing, Abnormality Management, Quality Skills Training and SPC; Identifies and coordinates training activities within the QA Department; Coordinates product, process and system audits; Develops and coordinates quality KPI and improvement activities consistent with the President’s New Year’s Message and business plan; Develops Project Planning and Management of the Quality Assurance department; Develops and monitors quality related policies and procedures; Communicates current quality situations and important issues to all members of management; Cooperates and interfaces with SRK and other Sumitomo Riko plants for best practice activities.

Develops and enhances air filter products to meet market needs consistent with cost, quality, installation and design guidelines. Manages engineering efforts to facilitate achievement of defined sales volume and profitability targets. Coordinates project management activities such as planning, testing, and production trials and guides projects through stage-gate process to ensure customer requirements are met or exceeded. Utilizes Product Data Management (PDM) system for change approval, document revision, and document release. Supports internal objectives and initiatives of the GVS Filtration business plan for new product, cost reduction, and manufacturing efforts Assist with development of GVS Filtration product strategies. Applies advanced level principles of product quality planning, evaluation, and control in support of the manufacturing and production operations of the organization. Responsible for applicable systems related to plant customer issues such as corrective action requests, supplier corrective action requests, nonconforming material reports, etc. Leads team of Quality Engineers, Quality Supervisors, Incoming Inspectors, PPAP Coordinator, Layout Technician and Shop Floor Support Technicians. Develop talents, manages performance and improves skillsets. Represents GVS Filtration at original equipment and aftermarket customers

Mendon, Michigan, Us

Develops and implements methods, standards and procedures for the inspection of product for conformance with customers’ requirements. Works from product specification and blueprints to write inspection instructions, procedures and check lists, ensuring all critical dimensions and characteristics are properly reflected. Ensures that assigned associates are provided with all training, instructions, documentation, methods, tools, instruments, and any other aids that may be required for the complete performance of their assigned duties. Investigates nonconformances and other complaints from customers and sales representatives. Coordinates efforts to identify root causes and implement appropriate corrective action. Organizes and performs work to collect, compile, maintain and summarize data to analyze quality performance. Prepares and submits quality reports showing performance versus quality objectives and significant trends. Recommends or implements corrective actions where appropriate. Serves as a facilitator for continuous improvement. Recommends improvements to the quality system, including procedures, standards, and equipment. Maintains calibration system for all measurement tools and instruments. Issues Quality Alerts and reviews with Quality team. Updates and improves work instructions. Assists Manufacturing Engineering with process DOEs. Performs Internal Product and Process Audits. Follows up on results and findings.

Mumbai, Maharastra, In

Supervises near a dozen direct reports; Liaison to Valeant for Documentation request; Approves procedures/specifications;Prepares NDA and IND annual reports for FDA; Release of Experimental material, raw material, finished product, and packaging components; Release of in-process bulk for shipment;Veries batchcards/finishing paperwork; Maintains Material Report database; Investigates and approve Material Reports; Maintains BSE/TSE database for all materials; approves new suppliers; handles Regulatory Inquiries; Drafts Annual Report Generation; trends raw material analysis; Maintains product monographs; Investigates complaints and maintain Customer Complaint database; Generates new specifications and procedures for Sun’s products; Revises documents; Approves QC procedures, specifications, and SOPs; Approves Stability Protocol; OOS approval/trending; Maintains stability schedule database and select annual lots for stability; Maintains Approved Vendors database; Manages Licenses; Maintains employee training records; Conducts cGMP training plant-wide; Provides support to International Regulatory in product registrations; Conducts internal and third-party audits; Raw material trend analysis; Reviews and approves labeling generation and changes, as needed; Provides Regulatory support for ANDA submissions; approves Contract microbial analysis; Input in hiring of staff members; Liaison to external auditors

Toledo, Ohio, Us

Responsible for all Quality Control functions at 3 production facilities and a company owned farm. Ensures federal, state and local compliance in regards to food safety and quality. Ensures the proper application of 21CFR. Maintains QC programs and documentation (kosher certificates; third party audit certificates, etc). Assists in FDA, USDA, state and third party audits. Ensures customer specifications are met. Investigates and responds to customer complaints. Member of the Food Safety Team. Maintains Nutritional Database and responds to customer requests for Nutritional Panels. Serves as a Corporate SQF Practitioner overseeing the successful implementation of SQF level 2 standard for three production facilities.

Toledo, Ohio, Us

Performs test/product development activities; test/project development scheduling; document generation (i.e. drafting protocols, reports, SOPs, etc.); coordinates and performs client sponsored studies related to the pharmaceutical and medical device industries such as population verification, AOAC disinfectant efficacy testing, biological indicator inoculation, bacterial filtration efficiency testing, microbial identification and more; analysis and interpretation of data; calculation of results; report review and signing; assures the accuracy and timeliness of technical reports; works directly with clients; ensures cGMP compliance with laboratory and laboratory documentation.Accomplishments:Drafted SOPs and worksheets and developed test methodology for AOAC Use-Dilution and Tuberculocidal Activity testing.Project Manager for Packing Validation client study involving accelerated and real-time shelf life studies, packing intergrity study, seal peel test, and burst test.Authored final report for client BI stability studyExecuted IQ/OQ protocol for Spectrophotometer

Performed quality control laboratory functions in full compliance with cGMPs; Supervised the day-to-day activities of eleven analytical technicians, microbiological technicians and incoming goods technicians; Conducted appropriate OOS investigations following systematic root cause analysis approach to identify and implement corrective actions; Managed laboratory instrumentation to ensure continued compliance to the Quality Program and cGMPs; Responsible for training and motivation of the laboratories; Motivated self-starters that can work independently with minimal supervision; Controlled the laboratory budget; Gave technical advice to production managers, Demonstrated a team work ethic.Accomplishments:Solved major quality assurance problems which temporarily halted productionRedesigned the company's environmental monitoring programImplemented weekly laboratory meetings to encourage better internal communicationsProduced monthly reports for CEO and Senior Management concerning lab analysis that will help produce better yieldsSupported customers through resolution and corrective action of Quality issues that reduced customer complaintsDrafted and directed the revision of all departmental Sop's for improved documentationCompleted FDA certified Better Process Control School trainingUsed MiniTab/Excel to provide data analysis that resulted in streamlined product specificationsFamiliarized with LIMS and SAP systems

Lawrenceville, Ga, Us

Performed all required microbiological analysis on raw materials, bulk batches, and finished products; Performed challenge studies; Maintained required cultures; Prepared necessary media and reagents; Maintained records on media and equipment; Worked with outside testing labs when required; Performed general lab analytical procedures; Performed environmental sampling and analysis; Trained compounders and warehouse personnel on proper sampling technique; Trained chemists on micro methods as needed; Performed all testing in an cGMP compliant manner; and performed related duties as assigned.Accomplishments:Investigated an increased frequency of Pseudomonas detection within the facility. This included finding the root source and collaboration with Quality Management and maintenance workers on the proper disinfection of equipmentTrained a technician in USP and BAM microbiological methods and procedures for routine testing and organism identificationAssisted in resolving issues of tank cleaning, disinfection, and validation of those proceduresLearned new lab techniques such as Celsis Rapid Detection

Ensured products were produced to meet or exceed consumer requirements; routinely sampled products to ensure the safety of the product; conducted analytical tests on incoming raw ingredients as well as final whipped cream products; performed failure testing; followed GMP’s, HAACP guidelines, and all safety rules explicitly; inspected product; completed appropriate testing worksheets; communicated with appropriate personnel; maintained lab and lab equipment; and performed related duties as assigned.Accomplishments:Conducted independent research into the detection capabilities of a handheld ATP bioluminesce microbial detection system to determine the appropriate microbial alert and action levelsGained industry experienceLearned new lab techniques such as viscosity and dry solids testing

Dayton, Oh, Us

Attended lectures; facilitated discussions; prepared lectures and review materials; held office hours; tutored students; managed and responded to course-related email; graded assignments; proctored and scored exams; maintained grading records; maintained course attendance records; calculated grades; acted as a liaison/mediator between students and the professor; prepared overheads; reviewed literature; and presented lectures.

Dayton, Oh, Us

Supported all aspects of day-to-day operations; participated directly in research; cleaned glassware; safely handled chemicals; radiation and biohazards; operated and maintained numerous laboratory items; performed administrative work; ordered supplies; performed a complete chemical inventory of the laboratory; photocopied articles; and established new inventory systems.

Ms, Molecular Biology

Bs, Biological Sciences