Sylvia K. McAlister

Biscoe NC *****

ad43sx@r.postjobfree.com 910-***-**** www.linkedin.com/in/sylviamcalister/

SUMMARY OF QUALIFICATIONS

Innovative, meticulous and results driven quality manager with 28 years of experience managing quality teams in audit readiness, compliance to Regulatory Requirements, training, root cause analysis and Process/ Document change control. Additional skill sets/experience includes the following:

QMS and MPS Document Management/ Change Control Program

Analytical Techniques (Chemical/ Physical; Qualitative and Quantitative)

Excellent working/implementation knowledge of cGMPs, cGLPs, and cGDPs

Strong RCFA Skills (A3, 8D, Ishikawa, P-matrix, 5 Whys and others)

Strong Computer Skills (Word, Excel, PowerPoint, Access Database, SharePoint, AVP electronic manufacturing program, Minitab, Smart Sheets, electronic COA platform)

Customer Satisfaction/ Supplier Certification Programs Manager

Regulatory Compliance and Audit Readiness Manager

Working/implementation knowledge of Six Sigma/Lean Manufacturing Tools

Effective communicator, both oral presentations and written media, at all levels of audience / Strong report writing skills

OEE and QMS KPI Reports (COPQ, DPPMs, OTIF, Complaints, Supplier Corrective Action Request, COGQ) generated weekly

Black Belt in Lean Manufacturing / Continuous Improvement

Red, Green & Yellow Belts in Lean Manufacturing

Certified Six Sigma Quality Engineer

Certified Internal Auditor

Train the Trainer Qualified

Working/implementation knowledge of Six Sigma/ Lean Manufacturing tools

Carolina Star Safety Compliance & Regulations Leader

PROFESSIONAL EXPERIENCE

PaperWorks Packaging, Inc., Mt. Gilead, NC July 2016 – Present

Quality/ Continuous Improvement Manager

Oversee and manage the quality team, continuous improvement initiatives, overall food safety and quality processes and compliance to IFS PACSecure Regulations.

IFS PACsecure Site Representative for ISO 9001, IFS PACSecure, HACCP and GMP programs

Maintain current knowledge of regulatory requirements that govern the facility.

Coordinate and align lean/ continuous improvement approach and principles.

Mentor lean/ continuous improvement approach and principles and monitor progress:

oFacilitate and conduct training on lean/ six sigma tools and events - (i.e., Kaizen, 5S, TPM, Set-up reduction, Standard Work, Visual Management, SQDC boards, MDI,)

oMaintained Lean Manufacturing Library and SME program for MGB certification.

Communicate professionally in written, oral and presentation form, project progress regarding formal milestones, issues, and benefit realizations to ensure management’s understanding of project status.

Maintain reporting systems for internal and external complaints, supplier non-conformance, conduct root cause investigations and follow up with corrective action.

Direct the activities, duties, and projects of the Quality Department to assure compliance to customer specifications, food safety and quality requirements.

Facilitate training and development in lean manufacturing techniques such as 5S, Kaizen, SMEDs, TPM, Standard Work, Visual Management, Process Capability Analysis, PDCA and other lean tools.

Communicate plant quality expectations and monitor performance relative to the objectives in a timely and effective manner.

Hospira, Inc., Clayton, NC May 2014 – January 2016

Change Control Specialist – Technical Transfer Project

Chair of the Change Control Board

Subject Matter Expert (SME) for the manufacturing process. Evaluate process/procedure changes for manufacturing process.

Monitor and report change management metrics to site leadership.

Drive continuous improvement of change procedures/results by promoting consistency in the change control process.

Pfizer, Inc., Sanford, NC 2004 - 2014

Senior Manufacturing Process Quality Engineer/Scientist

Championed continuous improvement projects for lean manufacturing practices. Subject Matter Expert (SME) for bacterial fermentation/purification process. Coordinated, reviewed, executed, tracked and ensured the compliance of all documentation/process changes, including the training material through SAP. Responsible for interaction with regulatory authorities regarding change controls, investigations and training revisions.

Designed and implemented manufacturing instruction documents and training for new building startup which included writing and executing change control documents, closing all documents on time to meet FDA approval timelines.

Eliminated unnecessary procedures 28% for working cell bank production by merging 14 manufacturing records into 4 master documents.

Eliminated product loss on manufacturing line by 100% by identifying errors in the analysis values for protein in 15 days.

Generated, executed and implemented change control documentation for protein analyzer on the manufacturing floor that reduced downtown by 40% and provided real time product quality data.

Reduced person-hours required to aseptically clean a manufacturing suite 25% by implementing a single dose disinfectant sprayer system that provided efficient and effective coverage saving 499 K per annum.

Reduced in-control process errors 12.5% by implementing training on the floor program that provided technicians with effective training on new/revised procedures without having to leave the process floor.

Led Carolina Star Safety Elements Team: Safety and Health Training Programs to prepare the site for OSHA and North Carolina Department of Natural Resources safety audits.

Validated the use of buffer heel volumes and reduced raw material usage by 20% while increasing process efficiency by 27%

Error-proofed site wide gowning and area classification instructions by converting 15 texts only documents into 5 picture process mapping visual aids.

Baxter Healthcare Corporation, Marion, NC 1996 – 2004

Raw Materials/Receiving QA/QC Inspection Supervisor 2001 – 2004

Ensured completion of all testing, including raw materials, in-process, final release, stability, and special project/protocol testing. Implemented and continuously improved quality systems to ensure compliance with testing Standard Operating Procedures and specification. Led laboratory audit-ready status efforts in understanding FDA, company, and other regulatory/quality requirements. Maintained a high level of expertise in current regulatory requirements and served as a laboratory resource for compliance with these requirements. Monitored testing techniques and reviewed accuracy of records and documentation generated.

oLed a team of 15 chemist and technicians in Receiving Inspection and Chemical Analysis of all raw materials received at North Cove

oReduce inspection time of sleeve stoppers by 25% by implementing Six Sigma and Lean Manufacturing Practices on incoming inspection.

oInterfaced with all External Auditing Bodies (FDA, TUV, OSHA, ISO, Division, Corporate) resulting in no observations for the area.

oImplemented and validated the POMS material management system for raw material release to production.

oPerformed Failure Modes and Effects Analysis (FMEA) on manufacturing operations to remediate trouble spots in the process.

oReduced inspection time of printed materials by 75% by implementing and validating an automated proofreading system.

Lead Validation Chemist 1998 – 2001

Developed and implemented validation activities to ensure that all processes, cleaning activities, and analytical methods meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices.

oEnhanced operations regulatory compliance by completing 120 product process validations in 18 months; finishing 6 months ahead of deadline.

oReduced environmental risks by developing and validating a High-Performance Liquid Chromatography (HPLC) detection method for deactivated drug substances in wastewater prior to release into the water treatment facility.

oReduced the cost of dextrose analysis by 57% by validating a HPLC method for dextrose concentration analysis.

Senior Lead Chemist 1996 – 1998

Coordinated and evaluated chemical laboratory workload. Provided technical support to chemistry laboratory personnel. Led/supported problem solving sessions using problem solving tools and methods to coordinate and/or lead investigation teams.

oLed a team of 9 chemists in Initial’s Chemistry testing lab.

oInitiated and completed OOS investigations for the chemistry lab.

oSubmitted specification changes and issued new Standard Operating Procedures to meet the lab’s change needs.

QA/QC Chemist I Jan. 1996 – Aug. 1996

Performed chemistry laboratory tests assuring products adhered to and met all quality release requirements.

oEnsured product quality regulatory compliance by performing initial, in-process and final chemical analysis on quality samples.

oObtained Baxter Chemist Certification

McDowell Community Technical College, Marion, NC 1998 - 2003

Chemistry/Biochemistry/Biology Instructor

Demonstrated and transferred theoretical information, practical skills, methods and techniques using personal experience obtained from working in the Chemistry laboratory.

Prepared and delivered lectures and led laboratory experiments to classes of 20 – 25 students.

EDUCATION EXPERIENCE

Western Carolina University, Cullowhee, NC

Bachelor of Science in Industrial Chemistry

Master of Science in Synthesis of Organometallic Polymers using Ferrocene, Fe(C5H5)2 as an electron pathway

North Carolina State University, Raleigh, NC

Bachelor of Arts in Language Arts and Literature

ACCOMPLISHMENTS/AWARDS

Certified Carton Manufacturing Technician

Certificate in cGMP Fermentation Operations

Certified Lean Six Sigma Manufacturing Engineer

Subject Matter Expert (SME) for Fermentation/Purification Processes (2006 - 2013)

Western Carolina University Graduate Student of the Year (1994, 1995)

Pfizer Global Services Excellence in Manufacturing Mission Award (2009, 2010, 2011, 2012, 2013)

Wyeth Operational and Quality Excellence Best Practice Award (2005, 2006, 2007, 2008)

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