Develop and perform in-house calibration and maintain orderly and timely documentation, to include, but not limited to maintenance, repair, and calibration and installation/validation protocols. Analyze calibration intervals and make recommendations to maintain validated process state and quality compliance. Operate equipment, as well as perform troubleshooting and analysis for the equipment. Serve as a mentor and trainer for the operation of analytical instrumentation. Assist in developing, coordinating and executing validation protocols for systems governed by federal regulations, including 21 CFR Parts 210 and 211 as applicable in the pharmaceutical industry. Coordinate validation related activities in regards to new equipment being deployed in GMP environments.
essential Duties and Responsibilities
Provide diagnostics, repairs, modifications, calibration and PM of laboratory instrumentation.
As necessary, prepare reagent mixtures, standard solutions, volumetric solutions, test solutions and indicators including NIST traceable standards, used in the calibration of analytical instrumentation.
Assist with identification, purchase and organization of spare parts, replacement parts or replacement instruments for calibrated instrumentation within QC.
Update and maintain the calibration management system and hard copy files with up-to-date information of existing and new equipment and facilities.
Manage outside calibration services and ensure compliance of these vendors with Company procedures and policies. Where economical and feasible, minimize vendors utilizing in-house personnel.
Assist with calibrations of QC equipment such as temperature/humidity monitoring probes, refrigerators, incubators, and stability chambers.
Maintain a close and cooperative working relationship with members of Quality Control, Quality Assurance and Validation staff and communicate relevant information to appropriate personnel in a timely manner.
Mentor others regarding the operation of equipment and the performance of certain methods or analytical techniques.
Assist in developing SOPs for the calibration/PM of a variety of components, analytical equipment, and instrumentation for Quality Control.
Audit data as requested.
Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
Follow good laboratory practices and good lab rules, such as housekeeping, maintaining thorough, timely laboratory records, including data recording and calculating and properly labeling solutions or materials.
Perform other related duties as assigned to meet departmental and Company objectives.
Knowledge and proficiency in a variety of the following: USP dissolution equipment, Gas chromatography (GC), high pressure liquid chromatography (HPLC), atomic absorption (AA), infrared spectrophotometer (IR), ultraviolet/visible spectrophotometer (UV/VIS), pH meter, flurometer, melting point apparatus, viscometers, muffle furnace, polarimeter, vacuum oven, distillations, titrations, centrifuge, sonicator, conductivity meter.
Knowledge of FDA regulated biotechnology or drug validation requirements including knowledge of FDA 21 CFR Parts 210 and 211.
Knowledge of USP and other compendial methods.
Excellent oral and written communication skills with ability to interact with scientists, engineers, and production staff, as well as to write cGMP compliant SOPs.
Proficient in the data acquisition system TotalChrom.
Knowledge of lab monitoring systems; i.e. SmartVue.
Proficient using a LIMS system.
PC proficiency using Microsoft Office products.
Good conflict resolution skills.
Highly organized and detailed.
Problem-solving and deductive reasoning skills.
Mentoring and training skills to effectively develop and teach others.
Self-motivated to work independently and assume additional responsibilities on own initiative.
Ability to perform preventive maintenance and calibration of analytical equipment.
Bachelor's degree in chemistry, pharmacy, engineering or related science; or the equivalent in pertinent, progressive related pharmaceutical industry work experience with increasing levels of responsibility.
Five years pertinent, progressive experience in the pharmaceutical or other highly regulated industry with two years' proven experience in calibration and/or validation, with particular knowledge of 21 CFR Part 210 and 211.
The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:
Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear.
Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.
The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:
Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.
Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.
Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.
Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.
Nesher Pharmaceuticals (Usa) LLC