Results-focused Pharmaceutical and Food Industry professional with strength in Quality Control, Quality Assurance and Manufacturing. Proactive leader with strengths in communication and collaboration. Proficient in leveraging quality and regulatory knowledge to promote a safe, pure and effective final product. that drives customer and client satisfaction. Adept at managing concurrent objectives to promote efficiency and influence positive outcomes. Strength lies within one's attention to detail, preparedness and desire to be a main cog in the success of the employer and the people the product serves.
Was sole representative of the quality department during my 12 hour overnight shift. Was responsible for all line clearances that gave the manufacturing department the ok to proceed with operations. Was there to triage all quality related concerns. Worked closely with all departments to deliver a safe, pure and effective pharmaceutical product. Responsible for finished product quality inspections that were needed during shift. Had complete authority to shutdown production if a need arose. Had to ensure manufacturing was taking place adhering to all cGMP and FDA regulations. Helped maintain legal retain samples and batch records for audit trail records. Reviewed in-process and finished batch records for accuracy. Dispositioned final batch records for possible release of product. Reviewed incoming testing results of raw materials and in-process API and excipient materials. Released these materials to manufacturing after review of material and paperwork. Used both physical and computer methods tp release, reject or place materials or finished product on quality hold status. Called / emailed various suppliers to get needed quality related documentation in order to disposition materials. Provided the oncoming QA associate of real time status and what would be needed for most of their shift. Was on call in case situations arose needing additional help or to fill in due to unforeseen circumstances.
The lab quality analyst was responsible for the in-process testing of the peanut butter coming off the various lines. A set number of tests had to be completed every 2 hours. If testing was failing, the controller was immediately notified to shutdown the line. Area supervisor was called and more samples were obtained to figure out the timing of the our of specification product. Once determined, the associated product was places on hold physically and in the computer system. The affected line would then offload the bad material and bring the lab a new start up sample. This process was repeated until the sample passed all the specifications. Only then would the line be able to continue production. Other duties included running Aflatoxin testing ever 2 hours and when a new start up sample came into the lab. As with the in process testing, the atox sample had to pass a certain scale. If not, the line was shutdown and the hold and start up process was repeated. Lab personnel also conducted hardness testing on finished product coming out of the temperature controlled warehouse. As before, product was placed on hold if it failed testing. Personnel also ran testing on incoming raw ingredients used in manufacturing. Communication and strict adherence to time management was a requirement as the testing process repeated every 2 hours.
My nightshift duty required triaging and accessing situations before escalating issues up the management ladder. Being a team player was critical. Had to know and adhere to cGMP and FDA regulations as well as internal SOP's. Safety was a main concern for the manufacturing plant and employees. My area was considered a part of the production are and as such, we have to be trained yearly on the safe operation of fire hoses, suppression systems and extinguishers in the event of an oven fire. This was a fairly common problem in the raw peanut [processing area. Constant vigilance was required by the operators. The quality lab team also had to have lower level skills in the manufacturing area before being considered and testing for a lab position. This is why we responded to all possible fire related incidents.
Blanch / Krunch Technician:
This was my level 1 skill in which I learned about the manufacturing process and the needed safety skills. The job itself was monitoring computer screens of my equipment while physically during rounds to make sure the equipment was effectively removing the skins from the raw peanuts. The Krunch part of the job only means that an extra step was taken, After the skins were removed, it went to a large piece of equipment that crushed the peanuts into a specific size of pieces that were used in the manufacturing of the Crunchy variety of peanut butter. The blanch / krunch skill was very hot and dirty as were all the other manufacturing skills. It was both an inside and outside job, although mostly inside. It was physically demanding given the extreme temperatures and the amount of stairs and ladders involved in performing one's duties. As stated earlier, safety was paramount. Had to watch out for each other as well as monitor the quality of the product being processed. Numerous job and safety trainings had to be completed in a timely manner. Again, a team player is a must.
Sampling of all incoming raw materials used in the manufacturing process of pharmaceutical drugs. Raw materials included all excipients, Active Pharmaceutical Ingredients ( API's ) and DEA controlled substances. DEA access required higher background checks and the ability to work under heightened stress and pressure due to the overall regulations of working with narcotics.
In charge of the FDA required Sample Retain Reserve Program
In charge of maintaining the daily sample and release metrics board
Group representative in the material disposition meetings
Helped release material for production
Lead person for the rejection of raw material
Worked very close with all departments
Safety was a critical factor in the sampling of material
Current Good Manufacturing Procedures ( cGMP ) expertise
Food and Drug Administration ( FDA ) expertise
Code of Federal Regulations ( CFR ) expertise
First aid / CPR experienced
Fire Fighting Training ( hoses, deluge systems, extinguishers )
Document Control system expertise
I have over 20 years of real world experience with working with Fortune 500 and other well regarded companies in the Pharmaceutical and Food industries. There is no substitute for real world experience in my opinion and my track record speaks to the breadth of this.
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