Manufacturing Quality Assurance
Resume:
CANDICE A HAWKSFORD
Email: abox4f@r.postjobfree.com
Address:
City: Salt Lake City
State: UT
Zip: 84109
Country: USA
Phone: 801-***-****
Skill Level: Any
Salary Range:
Primary Skills/Experience:
SUMMARY OF PROFESSIONAL SKILLS: 15 Years of experience in manufacturing including Nutraceutical, Pharmaceutical and injection molding operations, 12 years Supervisory, Training and/or Lead experience Inventory and supply coordination and Purchasing, Lean Manufacturing, Management of multiple shift staffing, scheduling, Operational tracking. Biopharmaceutical FDA, EU and cGMP manufacturing operations, ISO certified Aseptic Filling, Class 100- Pharmaceutical operations, 6 years in Polymer Science-based drug delivery technology for Clinical Cancer Trials, Parentaral Injectable Pharmaceuticals for human use. FDA and EU protocol requirements and Validation for Biopharmaceutical production, quality processes, 5 years experience in writing and implementing SOP's, Writing and performing Equipment Validation Protocols including FAT, IQ, OQ, PQ 's and Validation of CleanRoom systems and machinery and specific scientific purification processes. Proficient in both MS Office Mac and Windows
Educational Background:
High School Dipolma from University of Utah, Salt Lake City UT 1/2001 to 10/2012 (SLC Utah) -Engineering-Biomedical, and Earth Sci)
High School Dipolma from, Salt Lake City UT 1/2001 to 10/2012
Job History / Details:
Summary
SUMMARY OF PROFESSIONAL SKILLS:15 Years of experience in manufacturing including Nutraceutical, Pharmaceutical and injection molding operations, 12 years Supervisory, Training and/or Lead experience Inventory and supply coordination and Purchasing, Lean Manufacturing, Management of multiple shift staffing, scheduling, Operational tracking. Biopharmaceutical FDA, EU and cGMP manufacturing operations, ISO certified Aseptic Filling, Class 100- Pharmaceutical operations, 6 years in Polymer Science-based drug delivery technology for Clinical Cancer Trials, Parentaral Injectable Pharmaceuticals for human use. FDA and EU protocol requirements and Validation for Biopharmaceutical production, quality processes, 5 years experience in writing and implementing SOP's, Writing and performing Equipment Validation Protocols including FAT, IQ, OQ, PQ 's and Validation of CleanRoom systems and machinery and specific scientific purification processes. Proficient in both MS Office Mac and Windows
Accomplishments
Planned, directed, coordinated and assigned manpower to efficiently meet production requirements.
Proficiently supervised 2 high speed
production lines, oversaw materials inspection, scheduled production and conducted weekly physical inventories.
Decreased overall raw material spending at procurement by 40 percentage by discovering more cost effective ways to procure raw materials needed for production saving the company nearly $18K per quarter on one raw material alone.
Experience
10/2/2012 12:00:00 AM
Ben Venue Laboratories Boehringer Ingelheim Bedford, Ohio
Supervisor Aseptic Filling
Supervise manufacturing operations on 3rd(graveyard) shift, including setups/teardowns, basic equipment maintenance, Batch Record Review and completion, adherence to quality control standards, GMP policy, FDA Regulations and all quality controls.
Assessed and trained personnel for promotion to cross-functional operations.
Managed documentation of and training on production procedures and work instructions.
Maintained and communicated daily productivity and shipment reports for all departments.
Led regular stand-up meetings, events and continuous improvement projects with measurable goals.
Verified that all process control parameters were being documented and followed at all times.
Writing of SOP's, batch records and deviations and investigations.
Maintained and enforced a safe and clean working environment at all times. Planned, directed, coordinated and assigned manpower to meet aggressive production schedules.
Addressed all personnel issues promptly and professionally.
Drove daily production activities with effective communication and leadership.
Implemented root cause and corrective actions to remove production constraints and improve product quality.
10/2/2012 12:00:00 AM
Parker Hannifin Salt Lake City, Utah
Manufacturing Lead
Addressed all personnel issues promptly and professionally.
Drove daily production activities with effective communication and leadership.
Diligently maintained safety and quality standards.
Enforced a culture of lean manufacturing and continuous improvement while providing operational leadership.
Hold weekly meetings for manufacturing personnel and diffuse any conflicts within the group on all 3 shifts.
Assist Value Stream Leader in trouble shooting/research and engineering tooling methods.
Work closely with both Quality Assurance to develop and implement updated and proper training as needed for GMP/ compliance.
And to ensure quality standards are being maintained within current processes, testing, and sampling, etc.
10/2/2012 12:00:00 AM
Protherics, Inc Salt Lake City, Utah
Manufacturing Cleanroom Associate-Team Lead/Trai
Responsible for all Class 10,000, 1,000 and 100 clean room manufacturing operations, setups/teardowns, validation, basic equipment maintenance, Batch Record completion, and adherence to quality-control standards.
Lead and Train employees on all aspects of Polymer Synthesis and Purification operations including: gowning qualification, cleaning personnel, synthesis, purification, drug addition and filling in Aseptic filling rooms and autoclave.
Assist Process Development Team in trouble shooting/research polymer methods.
And work with incoming research project contracts for Manufacturing from other Biopharmaceutical and Pharmaceutical companies.
Procure Cleanroom supplies and submit orders for Laboratory equipment/tools, such as pipettes, scales & weighing instruments, chemicals, replacement parts, and sanitary stainless steel hardware, Autoclave operation and room control systems.
Write and perform Manufacturing Batch records, Validation and Qualification documents. Collaborated with the engineering team to adjust and modify production equipment.
Education
Present University of Utah Salt Lake City, Utah
SLC Utah) -Engineering-Biomedical, and Earth Sci
Currently working to complete Bachelors of Science in BioMedical Engineering
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