Overview
Quality Technician Jobs in Byhalia, MS at ABB
Company Overview
QOL Medical is a privately owned, patient-centric company founded in 2003 to focus on the acquisition and commercialization of orphan products in underserved markets, particularly in the field of gastroenterology. QOL Medical ensures an expanded clinical awareness and patient access for improved quality of life in the treatment of rare and orphan diseases. The Company currently markets two FDA-approved products: Sucraid® (sacrosidase) Oral Solution and Ethamolin® (Ethanolamine Oleate) Injection, 5%.
Position Overview
The 2nd shift Quality Control Senior Associate will be responsible for the development and validation/verification of Quality Control methods and equipment, assisting the execution of analytical and microbiological testing, and review testing data for disposition of components and products. He or she will be familiar with GMP/GLP/Data Integrity regulations and maintain appropriate records of all work performed, as well as assist in the management and performance of calibration, qualification, and maintenance of analytical and support equipment.
Primary Responsibilities
Follow procedures and guidance associated with GMP/GLP and data integrity. Maintain appropriate records of all work performed following GMP/GLP guidance documents. Specifically:
Perform analytical and microbial l testing.
Perform data entry and trending evaluation related to test results.
Operate analytical, microbiological, and environmental monitoring equipment.
Manage and perform calibration, qualification, and maintenance activities for analytical and support equipment.
Develop and implement processes for the validation, calibration, and operation of laboratory equipment and systems.
Develop, transfer, and validate reliable test methods.
Supports the quality team with product-related quality systems documentation and continuous improvement efforts.
Assist OOS investigations and other associated quality systems.
Develop, review, and revise SOPs, associated controlled documents, and methods.
Assist with the inspection, sampling, and dispensing of components.
Assist utilities and environmental monitoring sampling.
Review and maintain testing data for disposition of components and products.
Provide hands-on training for all new and current quality control personnel.
Maintain inventory of chemicals, glassware, and other lab-related consumables and performs regular cleaning and maintenance of lab and cleanroom spaces.
Participate in audits.
Other duties, as assigned by management.
Required Qualifications, Skills, and Abilities
Educational background in Life Science and/or Engineering, preferably in Microbiology or Chemistry.
Master’s degree or bachelor’s degree with at least two (2) years of experience within a GMP-regulated environment or associate degree with at least four (4) years of experience within a GMP-regulated environment, or high school with eight (8) years of experience within a GMP-regulated environment.
Working knowledge of cGMP, ICH, and FDA rules and guidance required.
Demonstrated accuracy, thoroughness, organization, preparedness, and excellent problem-solving skills.
Strong written and oral communication skills.
Strong organizational and time management skills.
Planning capabilities, multi-tasking ability, and organizational skills that result in efficient operation.
High level of integrity and the ability to maintain total confidentiality regarding all information associated with duties.
Able to work under pressure and to mitigate/resolve conflicts/challenges with excellent planning and prioritization.
Model high ethical standards and a professional image, acting as a positive representative within and outside the company.
Experience with standard software packages such as Microsoft Word, Excel, Access, PowerPoint, Adobe Acrobat, office scheduling software such as Microsoft Outlook, E-mail, and internet web browsing software.
Proficient English speaking, reading, writing, and editing/proofing skills to support the business environment.
Proven track record of being self-managed and successfully working within a diverse community.
Position Type / Expected Hours of Work
This is a second shift, full-time, permanent position, Monday through Friday, which typically involves 40+ hours a week of work during evening standard operating hours. On occasion, the employee may need to respond during early/late hours to resolve unforeseen issues arising from the needs of manufacturing projects. This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. However, while performing the duties of this job, the employee may be exposed to fumes or airborne particles, moving mechanical parts and vibration. The employee may also be occasionally exposed to a variety of extreme conditions at manufacturing job sites. The noise level in the work environment and manufacturing facility may be loud. This position works in an environment in which safety, environmental, and health concerns are considered at all times.
Language Skills
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports and business correspondence. Ability to effectively present information and respond to questions from various groups of people including managers, fellow employees, and customers, both internal and external.
Reasoning Ability
Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Physical Ability
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to sit, stand, and walk for extended periods of time
Ability to occasionally lift and/or move up to 35 pounds
Ability to speak into a telephone in the English language and clearly pronounce and articulate information
Ability to use a keyboard regularly for 8-10 hours per day, 5 days per week
Job Type: Full-time
Benefits:
401(k)
Dental insurance
Employee assistance program
Flexible schedule
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Professional development assistance
Vision insurance
Schedule:
8 hour shift
Night shift
Weekends as needed
Application Question(s):
Do you need, or will ever need, sponsorship to work in the U.S?
Education:
Bachelor’s (Preferred)
Experience:
CGMP: 2 years (Preferred)
Work Location: In person
Title: Quality Technician
Company: ABB
Location: Byhalia, MS
