Manager Quality Assurance
Resume:
STEPHANIE ERTHAL
*** ********** ****, *******, **. 63021 314-***-**** acxqcv@r.postjobfree.com
PROFESSIONAL SUMMARY
I am a looking for a Quality Assurance position to perform Quality Assurance tasks in a GMP environment. I have recent experience in the GMP environment manufacturing efferevescent tablets and medical devices. Experience in the generation and reviewing of batch records, receiving raw materials, production line clearance, writing of C of A’s and Out of Specification Reports and updating SOP’s as well as OSHA and GMP training for 100+ employees in a fast- paced manufacturing facility are a few of the skills I have acquired. Past positons include QC Analyst, QC chemist as well as analytical chemist.
SKILLS
Attentive to detail, self-motivated, self-disciplined, and ability to work in a fast-paced, quality-environment.
Ensuring work is performed and documented accurately accordingly to approved standard operating procedures.
I am very outgoing, energetic, easy to approach as well as responsible and professional.
Works well by myself or in a team environment.
Great communicator in small or large team environments. Participates in problems/conflicts as well as creating new ideas/procedures.
Highly energetic/thrives on “wearing many hats”. Loves a challenge.
WORK HISTORY
04/16 to 11/16
QA Manager, Nomax, Inc.
Generated and reviewed finished product batch records, and ensured that all manufacturing documents are free of deviations.
Participated in all OOS investigations and corrective/preventative actions that resulted from production deviations.
Created C of A’s for finished product when required by customer.
Coordinated outside testing on finished product including micro, heavy metals as well as environmental testing.
Approved major cleaning of the processing rooms, line clearance checks and of all packaging processes at the beginning of the day.
Reviewed, revised and created documents related to QA, such as SOP’s, Specifications, Cleaning Procedures and Validation Studies.
Worked with HR, QC, Production and Maintenance to track/update and keep current the training program at Nomax. (cGMP, Safety, and Job Specific Training).
Worked with the department managers to assure that the personnel under them are properly trained on time and document the training efforts as part of the QA responsibilities.
12/15- 02/15
QC/Data Analyst, Utilimap
Virtually built and final quality check on utility poles built using QCalc Pro software.
Utilized propriety software as well as Excel and engineering tables.
Worked in fast-paced, high energy/volume setting using my communication and analytical skills.
1994-2011
Analytical Chemist, Whitmire Research Laboratories (now Basf)
Supported the R&D team as well as the manufacturing facility by analyzing product in a timely manner with the utmost accuracy. Utilized many instruments and their software as well as maintenance. Followed specific regulations through GMP and laboratory LIMS’s. Learned the importance of regulation, accuracy and team work in a multi-faceted laboratory.
1990-1994
Quality Control Chemist, Chevron
Supported the high volume manufacturing facility by analyzing product through LIMS. Was mainframe manager and responsible for the updating and creating new product titles within the software. Learned to read and compile large amounts of data and accurately analyzing using my good Math skills. Gained much experience in the maintenance of HPLC’s and GC’s. Learned Good Manufacturing Practices and FDA requirements.
1989
Chemical filler, Sigma
Summer internship filling drug/chemical orders in controlled environment in a fast paced high volume facility. Learned to produce great work in timely manner with accurate results with various measurements.
EDUCATION
1986-1990
B.S. Mathematics, Minor Biology Millikin University
1992-1993
IT, Webster University
PROFESSIONAL REFERENCES
Kay Polak, Document Control Lead, Nomax, Inc.
acxqcv@r.postjobfree.com
Tonia Dement, Document Control Assistant, Nomax, Inc.
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