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Sterile Filling (Vial Inspector)

Location:
Raleigh, North Carolina, 27613, United States
Salary:
$16.75
Posted:
October 12, 2016

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MARGARET LENNON

**** ***** **** ***** *** #****

Raleigh, North Carolina 27613

Phone: 919-***-****

919-***-****

acw035@r.postjobfree.com

MANUFACTURING ASSOCIATE / LAB TECHNICIAN

professionalism – quality – safety

A challenging position in a progressive, team-focused pharmaceutical company. Position and career focus is to improve product quality and ensure compliance with state and federal regulations.

SUMMARY OF QUALIFICATIONS

Results oriented professional with 10+ years experience in diverse industries and in multi-functional manufacturing environments with attention to quality control and safety. Demonstrated skills in:

Inventory Operations / Technician Leadership

Quality Inspections / Approved Procedures

Equipment Operations / Maintenance

SOP / cGMP / OJT Compliance

Workstation Fundamentals

Regulatory Compliance / State & Local Laws

Problem Resolution Management

Calibration / Cleaning Inspection Equipment

Flow of Materials / On Test / Pending

Acceptability of Raw Materials

Detail-Oriented / Well Organized

Glassware / Stoppers / Filter Inspections

Supplier Certifications

Adaptability of Priorities Scheduling / Packaging / Quality Management

SELECTED ACCOMPLISHMENTS

Awarded Awesome Client-Site Employee Achievement by A.C.E. Employee Belcan TechServices’ Team in 2011.

Conducted semi-annual inventory of equipment parts.

Operated granulation equipment such as: Kettle, Oscillating Grinder, and Quadro Mill Outlet to produce intermediate and bulk stock for raw materials.

Controlled and regulated stock production by batch records.

Verified raw materials had the correct codes, weight, and were within expiration limits.

Operated injection, injection blow and stretch blow molding equipment; checked for proper meter readings of water and air.

Adjusted machine controls for minor variances of pressure and temperature.

Logged and analyzed data for conformance to production standards.

Operated decorating equipment; adjusted ink controls for proper print on bottles.

Adjusted and replaced blades and pads.

Performed visual checks of finished items for proper quality through constant rotational surveillance of all cases in the area.

Maintained production records and equipment logs, labels, and cases of finished products.

Totally dependable in carrying out detailed responsibilities to a successful completion.

EDUCATION & TRAINING

Orrum High School, 1684 S.Creek Rd. Orrum, NC. 28369 910-***-****.

High School Diploma, June 4, 1982

ELECTRONIC TRAINING INSTITUTE Raleigh, NC

Certificate of Completion, 2007. 140+ hours of classroom training.

Selected courses:

Theory; Soldering; De-soldering; Wire Wrapping (testing units; Harness Wiring; Cable Wiring Schematics; Blueprint Reading; Static Awareness; Industry Safety/Workmanship Standards.

PROFESSIONAL EXPERIENCE

GRIFOLS BIOTHERAPEUTICS (through Belcan), Clayton, NC

Sterile Filling Vial Inspector, August 2015 – Present

Responsible for a variety of tasks, including weighing vials and inspecting vials for defects and recording accurate data in the inspection of product/packaging of biological products. Perform all duties in strict adherence to cGMP guidelines. Preparing vials for sterile filling areas and placing vials into the sterile filling cages for vial washing.Seidenader vials inspected and pre-inspection for SFF and the final.

QUALITEST PHARMACEUTICAL, Charlotte, NC

Packaging Operator, February 2015 - April 2015

Responsible for proper operation of all scales, including print out, zeroing setting tare, daily calibration verification, housekeeping and materials handling. Performed various inspections on pre-formulated drug substances and finished product vitals, operated equipment, adjusted ink controls for proper print on bottles. Met all compliance and safety guidelines and followed protocols according to cGMPs standards, procedures and company policies. Read and applied All safety SOPs, and company CGMPs.

PUROLATOR FILTERS NA LLC, Fayetteville, NC

Inspection Operator, July 2014 – November 2014

Worked in the manufacturing area on a number of different projects. Was responsible for unloading filters, checking for defects, logging defect filters into the computer and maintained finished items for proper quality through constant rotational surveillance of all case in the area. Maintained production records, equipment logs and labels according to all compliance and safety guidelines. Performed area clean-up as defined in CGMPs, SOPs, and other departmental procedures.

MONARCH, Lumberton, NC

Administrative Assistant, May 2014 –June 2014

Assist in front desk / medical records responsibilities, greets visitors and checking people in and out for appointments.

THE UNIVERSITY OF NORTH CAROLINA AT PEMBROKE, Pembroke, NC

Cashier, January 2014 –February 2014

Re-stocking shelves with current materials, cashier, provide customer service to students and responsible for assisting the students on a daily basis.

BAYER CROPSCIENCE (through Belcan), RTP, NC

Lab Technician, April 2013 – April 2013

Responsible for sample processing: preparation and grinding. Responsible for sample logistics: receiving and maintaining inventory. Responsible for sample extraction for use in laboratory analyses. Act as responsible individual for simple laboratory equipment, including routine maintenance. Responsible for contacting manufacturer’s in regards to equipment maintenance, calibration, etc. Serves as GLP study personnel under the supervision of a GLP study director. Keep laboratory supplies organized in storage room. Assist laboratory personnel with safety inspections. Read, understand, and utilize standard operating procedures (SOPs). Record and report the results of technical experiments. Transport dirty laboratory glassware to dishwashing area and put clean glassware away. Some routine to technically more diverse assignments. Ensure use of most competitive (cost, timing, quality) technical approaches. Communicate with supervisor on deadlines and the advancement of projects. Ensure compliance with all existing good laboratory practice, stewardship, and safety standards in the area of responsibility.

BAYER CROPSCIENCE (through Belcan), RTP, NC

Plant Specialist, February 2013- February 2013

Perform generalized greenhouse work such as planting, propagation, watering, fertilizing, harvesting and maintaining various crop plants. Maintain greenhouses and work areas. Assist in experimental preparation by planting, maintaining, collecting data and harvesting according to specific protocols. Collect plant tissue samples for various research purposes. Use electronic equipment (computer, barcode scanners, cameras, seed counters or physiological data collection devices).

GRIFOLS/TALECRIS BIOTHERAPEUTICS (through Belcan), Clayton, NC

Quality Operations Incoming Inspection, March 2011-March 2012; Nov 2009-Dec 2010

Ensured all received materials meet all product specifications and requirements. Determined acceptability of materials based on technical review of inspection records and specification for conformance. Performed inspection of raw materials (glassware, stoppers, labeling, filters, tubing, hose, and cleaning/sanitizing agents). Led and performed physical test, visual inspections and measurements of materials. Verified supplier certifications against purchase specifications. Disposition batch acceptance based on the review of inspection and test results. Directed flow of materials in and out of on-test, pending, and reject areas. Verified integrity of samples.

CATALENT PHARMA SOLUTIONS, Raleigh, NC

Lab Technician, March 2008 – October 2008

Performed various inspections on pre-formulated drug substances and finished product vitals. Ensured quality and integrity of data or batches by recording and verifying documentation was complete and accurate. Determined acceptability of a raw material batch based technical review of inspection records and specifications for conformance and acceptability. Performed inspection of raw materials that include glassware, stoppers, labeling, filters, tubing and hose, and cleaning/sanitizing agents. Responsible for verification of supplier certifications against purchase specifications; worked with purchasing to resolve any issues. Provided disposition batch acceptance based on the review of inspection and testing results. Directed the flow of materials in and out of an on test, pending and reject areas. Performed visual inspection of final product reserve samples and stability samples.

BASF (through Kelly Scientific), Durham, NC

Lab Technician, April 2007 – August 2007

Documented process of cross-pollination procedure, operated, maintained and validated equipment. Met compliant and safety protocols with cGMP guidelines, procedures and company policies. Coordinated with team members during immasculation process.

AJINOMOTO (through Kelly Services), Raleigh, NC Plant

Production Technician (Mixing), May 2006 – September 2006

Operated and controlled mixing, blending, and repacking processing equipment and related systems needed for the production of mixes, repacks, and blends. Met all compliance and safety protocols with cGMP guidelines, procedures, and company policies. Cooperated and supported the team environment, providing professional communication and project support. Key areas responsible for included: safety, production, documentation & records management, housekeeping, material handling, time management, and independent actions.

PROLOGISTIX (through Staffing Solutions), Raleigh, NC

Machine Operator - GSK, November 2002 – May 2003

Worked in the manufacturing area on a number of different projects. Responsible for unloading medication and placing on production line. Performed logistics and other warehouse/inventory functions during this time. Read and followed all safety guidelines and SOPs.

AVX CORPORATION (through Express Personnel), Raleigh, NC

Production Operator, July 2002 to September 2002

Production Operator, March 2002 – July 2002

Worked in the manufacturing area on a number of different projects. Entered data codes on record. Weighed bags of wear on scale, then matched card and bags in accordance with SOP. Performed equipment and area clean-up as defined in cGMPs, SOPs, and other departmental procedures.

Various Other Employment:

CREE, INC., Durham, NC

Machine Operator I, June 2000 to Dec 2000

STAFFING ALLIANCE, Zebulon, NC

Packaging Operator, Aerosols/Vials, July 1999 to December 1999

BRISTOL-MYERS SQUIBB, Morrisville, NC

Certified Compounder, April 1997 to Aug 1998

Injection Molding Machine Operator, April 1996 to April 1997



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