Lab Technician - Exp

Lab Technician - Exp is Required role at Millennium Soft Inc

Level of

Experience:

Entry Level

Employment Type: Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

Shift: 9:00am - 6pm Monday through Friday

Position: Lab Technician

Location: Covington, GA

Duration: 6 Months

Total Hours/week: 40.00

Client: Medical Devices Company

Job Category: Healthcare

• 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 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.

• 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.).
• 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 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…