Customer Service Quality Control
Resume:
Cindy Wynn
*** ********* **** *******, ** *****
**********@*****.***
Education
Stratham Vocational Technical College
Associates in Science 2001
Ashford University
Bachelor of Arts, Organizational Management 2012
Experience:
June 2014-Sept 2015, Lonza, Portsmouth, NH
QC Supervisor
Excellent customer service, organizational skills and communication skills.
Office management, administrative and research
Conducted internal audits; experience dealing with FDA inspections.
Responsible for ensuring that the customer product batches are released in a timely manner by supervising the review of laboratory data and the closeout of deviations.
Perform annual reviews of direct reports.
Experience with: QC testing of in-process, finished product and stability samples. Responsible for data and logbook review.
Responsible for overseeing adequate cGMP and technical training and scheduling activities for all direct reports ( QC Analysts). Ensures documentation for training files are completed by each analyst.
Scheduling of all biochemistry and/or laboratory testing.
Understands regulatory requirements and Lonza policies pertaining to area of responsibility.
Report writing (Change Control, Deviations/Investigation) and SOP Writing and Review.
Supports customer and regulatory agency interaction as required.
Work interdepartmentally to ensure that work orders, preventive maintenance, compliance and documentation issues are resolved and to enhance communications at all levels.
Demonstrated ability to manage competing demands, receive constructive feedback, and maintain adaptability and flexibility.
Demonstrated ability to take ownership of selection process and successfully manage a high-volume and complex workload in a fast-paced environment and to provide insightful analysis.
Act as a technical lead; Execute new hire operator and existing operator training for standard work/procedures.
Technical aptitude with PC literacy skills with an ability to learn and apply technical information in a fast-paced, demanding work environment.
April 2011 – June 2014, Thermofisher, Portsmouth, NH
Quality Control Lab Lead (manufacturing)
Techniques utilized include specialized tissue culture assays, functional assays, proliferation assays, immunostaining, cell separation, and tissue culture.
Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.
Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.
Supply quality control data necessary for regulatory submissions.
Participate in out-of-specification and failure investigations and recommend corrective actions.
Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.
Serve as a technical liaison between quality control and other departments, customers, and vendors.
Train other analysts to perform laboratory procedures and assays and Fill in as an analyst to help meet schedule requirements.
Participate and support in PPI –Lean Enterprise projects as requested and Implements 5S in various areas of manufacturing as well has the lab area.
Embodies the 4-1 values (integrity, intensity, innovation, involvement) exceeds expectations.
I have assisted in analyzing and correcting problems encountered during production in order to perform work according to SOP’s.
Assist with addressing employee relations concerns and with semi-annual employee performance reviews by providing the supervisor input and providing employees constructive feedback.
I provide orderly and efficient changeover for all incoming shift leaders and supervisors.
Execute new hire operator and existing operator training for standard work/procedures
Stop production for safety issues / concerns when needed. Hold team accountable for all safety, and environmental policies and procedures
Works closely with manager and maintenance to schedule and prioritize downtime on equipment for repairs and maintenance; recommends and performs (when applicable) preventative maintenance and improvement ideas; makes decisions with limited direction (equipment/operations, shut down equipment when performance parameters are exceeded);
Works with other team leaders to solve manufacturing problems
Communicate with management in an efficient manner; meets or exceeds quality requirements/standards in manufacturing area
Works on special projects as directed by management; check/respond to emails at least once per day, preferably during 1st hour of shift/
Ensure daily housekeeping duties are adhered.
June 2003 – June 2007 Shire Pharmaceuticals, Cambridge, MA Quality Control Biochemistry/Cell Biology Analyst
Testing of multiple in process samples, stability samples and release samples for drug substance
Creation and revision of standard operating procedures, reviewing of raw data for cGMP’s, Creating attachments for assay controlled documents
Trending of data for senior management
Maintenance of inventory for critical antibodies
Use of LIMS for tracking and testing of samples
Qualified trainer of new analysts
Assists with transfer of validation protocols and development testing to the quality control laboratory
Maintenance of training file to ensure all training is current and up to date
Assists with the continuous improvements to QC processes and equipment
Management support when needed
Maintained multiple cell lines utilizing aseptic sterile technique.
Prepared solutions and reagents.
Maintained all equipment and logs for the cell biology lab
Performed aseptic sampling and technique for re-qualification of Reference Standards.
Reviewed raw data for cGMP’s for release of drug substance.
Created attachments for all assay controlled documents
Prepared testing schedule for analysts
Computer Skills
LIMS, SAP, MasterControl, Windows, Microsoft Office, Microsoft Word, Microsoft Works, Microsoft Excel, Power Point, Adobe, Taleo, Photoshop.
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