Quality Technician,
Durham, NC, US, 27703
Ingersoll Rand is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
Ingersoll Rand is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
Job Summary:
Performs analytical testing on a variety of raw material and product using analytical equipment and instruments. Keeps accurate records of testing and analyzes results. Requires knowledge of industry specific tests, testing equipment, and pharmacopeial testing. Familiar with standard concepts, practices, and procedures for good manufacturing practices (GMP). Performs a variety of tasks. Leads / mentors and trains other Test Technicians or Manufacturing Operators on testing procedures and documentation practices.
*Essential Job Duties:
· Supports daily testing activities for verification of utilities systems, supplier materials from the supply chain process and products for distribution
· Coordinates with Production Control on the priorities in order to assure schedules are met
· Performs tests and assyas via thourough understanding of laboratory standard operating procedures and instrumention.
· Well versed in major areas of chemistry including wet chemistry, HPLC and chromatographic analysis and/or microbiology.
· Completes documentation and analyzes results to create certificates of analysis or other reports as needed
· Writes and revises inspection and sampling procedures, test procedures, instrumentation procedures, data handling procedrues, and laboratory documentation such as forms or investigation templates.
· Directs, performs, and/or reviews inspection, sampling, and testing of parts, components, chemicals, materials, and products to determine conformance to standards
· Creates and/or approves specifications for raw materials and products
· Performs and/or approves abbarent result or out-of-specification laboratory investigations and tracks/trends all aborted assays, invalid assays, and out-of-specification results
· Assist in control charting and results analysis over time
· Identifies any laboratory generated deviations or non-conformance issues, intiates and/or owns proper quality records to investigate events
· Provides training and mentoring to staff on testing procedures, compliance to regulations, data integrity, and laboratory safety; Quality Control Subject Matter Expert
· Coordinates documentation and test activities concerned with development, procurement, installation, qualification and calibration of instruments, equipment and control devices required to testing, recording, analyzing, and/or reducing test data
· Perform periodic data integrity laboratory audits to ensure good documentation practices and orphan data is not being generated, retesting without proper approval is not being conducted, and data is not being altered, erased, or discarded
· Ensures laboratory area is audit ready and complies with regulatory requirements and local or global procedures
· Preferred experience in method development and method validation
Non-Essential Duties:
· Operates hand truck to move material
· Initiates Supplier calls to resolve discrepancies with material or laboratory services
· Conducts periodic review of subcontractors&apos testing processes to determine adequacy and capability; tracking and trending any laboratory supplier issues including invalid tests performed, laboratory investigations performed, and quality issues by contract laboratory organization (laboratory services supplier score cards)
· Maintains laboratory equipment and instruments in good working order including cleaning and ensuring proper calibration and preventative maintenance are performed
· Assists site and quality during new product introduction, regulatory inspections, and customer and internal audits
· General cleaning and equipment care duties
· Laboratory supply inventory and ordering
· Chemical reagent and media expiry tracking
Qualifications:
· Must be able to access shared database with government programs (U.S. Citizen or Permanent Resident of the U.S.).
· Bachelor of Science degree in chemistry, microbiology or related field from an accredited college plus at least four (4) years of related quality control experience and/or training; or an equivalent combination of education and experience
· Preferred two (2) or more of the years of experience in an FDA regulated industry
· Knowledge of analytical or microbiological techniques such as HPLC, GC, UV-Vis, FTIR, ICP-MS, wet chemistry, titration, total plate counts, microbial limits testing, and water analysis
· Excellent communication and writing skills
· Attention to detail and accuracy
· Expert knowledge of general computer applications such as MS Office, project management software, database software, and electronic document control systems
· Knowledge of application specific software related to chromatography, spectroscopy, total organic carbon testing, kinetic endotoxin testing, particulate analysis and other analytical methods
· Strong multi-tasking and problem solving skills
· Aseptic processing industry experience preferred
· Ability to adapt and be flexible in the face of changing priorities and deadlines
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing 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 employee is occasionally exposed to wet or humid conditions (non-weather); fumes, or airborne particles. The employee is frequently exposed to work with toxic or caustic chemicals, sensitive instrumentation, and near moving mechanical parts. The noise level in the work environment is usually moderate
Ingersoll Rand Inc. (NYSE:IR), driven by an entrepreneurial spirit and ownership mindset, is dedicated to helping make life better for our employees, customers and communities. Customers lean on us for our technology-driven excellence in mission-critical flow creation and industrial solutions across 40+ respected brands where our products and services excel in the most complex and harsh conditions. Our employees develop customers for life through their daily commitment to expertise, productivity and efficiency. For more information, visit www.IRCO.com.
Ingersoll Rand Inc. (NYSE:IR), driven by an entrepreneurial spirit and ownership mindset, is dedicated to helping make life better for our employees, customers and communities. Customers lean on us for our technology-driven excellence in mission-critical flow creation and industrial solutions across 40+ respected brands where our products and services excel in the most complex and harsh conditions. Our employees develop customers for life through their daily commitment to expertise, productivity and efficiency. For more information, visit www.IRCO.com.
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Nearest Major Market: Durham
Nearest Secondary Market: Raleigh