MillenniumSoft Inc ยท 1 month ago
Lab Technician - Exp is Required
Covington, GA
Full-time
Onsite
Entry Level
1+ years expMillenniumSoft Inc is a company that operates in the medical devices sector, seeking a Lab Technician to support its Quality Department. The role involves conducting product testing, performing complaint investigations, and ensuring compliance with regulatory requirements.
Staffing & Recruiting
No H1B
Responsibilities
Represents the Corporation, Division and Quality Department in a professional manner
Provides support to Project Teams and Quality Department
Responsible for all product testing in the Complaint Laboratory
Provides Quality Engineering technical support to assist in resolving quality issues, including but not limited to complaint review
Performs complaint investigations for all UCC products and as applicable, for OEM manufactured products
Creates investigation files in the complaint system (Trackwise)
Sets up, safely operates, and maintains laboratory equipment and testing instruments
Performs tests and experiments in accordance with the requirements of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
Develops and maintains a working knowledge of UCC policies and procedures and ISO and FDA requirements
Maintains accurate data, analyzes and assists in drawing conclusions
Performs tasks accurately and with great attention to detail
Must be able to work in a biohazard environment and comply with safety policies and procedures outlined by policies
Ensures compliance to Department and Division procedures
Interfaces with manufacturing facilities, suppliers, and Product Legal Manufacturer (PLM) groups
May present data findings to peers, engineering and management staff
Qualification
Required
Represents the Corporation, Division and Quality Department in a professional manner
Provides support to Project Teams and Quality Department
Responsible for all product testing in the Complaint Laboratory
Provides Quality Engineering technical support to assist in resolving quality issues, including but not limited to complaint review
Performs complaint investigations for all UCC products and as applicable, for OEM manufactured products
Creates investigation files in the complaint system (Trackwise)
Sets up, safely operates, and maintains laboratory equipment and testing instruments
Performs tests and experiments in accordance with the requirements of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
Develops and maintains a working knowledge of UCC policies and procedures and ISO and FDA requirements
Maintains accurate data, analyzes and assists in drawing conclusions
Performs tasks accurately and with great attention to detail
Must be able to work in a biohazard environment and comply with safety policies and procedures outlined by policies
Ensures compliance to Department and Division procedures
Interfaces with manufacturing facilities, suppliers, and Product Legal Manufacturer (PLM) groups
May present data findings to peers, engineering and management staff
Minimum 1 to 3 years of experience with regulated industry, including co-op/internship experience
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily
The requirements included in this job description are representative of the knowledge, skill, and/or ability required
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Basic knowledge of medical device regulation, industry or international standard
Good laboratory skills, along with a working knowledge of laboratory bench methods and associated equipment
Understanding of laboratory instrumentation
Good understanding of OSHA requirements, Quality Systems Regulations (QSR), Good Laboratory Practices (GLP), ISO, AAMI, and FDA Guidelines, as well as any other regulations/requirements as they pertain to the laboratory
Excellent communication skills (verbal, written, and presentation)
Ability to effectively manage time and manage priorities to meet deadlines
Ability to handle multiple task assignments
Ability to interpret Corporate, Division and Department Procedures
Ability to work with minimal supervision
Ability to read, analyze, and interpret general technical procedures or government regulations
Ability to write simple reports and business correspondence
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
This position requires good judgment. All product and process development are to be carried out according to the applicable laws and regulations
When in doubt, the incumbent should source out the appropriate information via internal and external resources
Highly variable operations performed daily from complex regulatory and engineering decisions to routine administrative functions. Interpretation of regulations (GMP, ISO 13485, EN46001) into standards and procedures as required. The ability to explain these interpretations to Plant, Division, Corporate and representatives of Regulatory bodies is necessary
A great deal of work must be initiated through a detailed knowledge and understanding of the job function, the establishment of plans to attain the end goal
Decisions made by this person could have significant regulatory and financial implications. Furthermore, this person's decisions could have a significant impact on health care practitioners and the welfare of their patients
While performing the duties of this job, the employee is regularly required to sit, walk, talk or hear
The employee will sometimes be required to move around in lab environment
Specific vision abilities required by this job include close vision and color vision
May occasionally lift objects up to 25 lbs
Work environment requires operating and maintaining laboratory test equipment and measurement instruments
Preferred
Technical or associate degree in a science field is a plus
Prior laboratory experience desirable
American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) is a plus
Proficiency with using MS Excel (pivot tables, v-lookup, etc.)
Company
MillenniumSoft Inc
Hire us to hire for you Staffing is not a straightforward activity.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Sailaja Mashetty
Partner - Customer Sucess
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