Quality Control Associate - (Biotech / Diagnostics)

Job Description

Job Description

Onsite Position - Local Candidates

The Quality Control Associate – Sequencing Cartridge Operations will be an integral part of a team that performs cartridge assembly and systems testing. This individual will be responsible for the setup, execution, monitoring and data analysis of all Quality Control release activities associated with the Sequencing Process.

The individual will be responsible for review, generation and sign-off of quality documentation. The ideal candidate will be responsible for interfacing with highly complex systems and controls in an ISO 13485 and cGMP manufacturing environment. The individual will maintain areas in high state of inspection preparedness by maintaining equipment, records and laboratory environment in order to comply with regulatory requirements utilizing current regulations and Operating Procedures (OP). Additionally, maintains production documents and investigates laboratory exception events and works independently with general guidance from senior team members

Requirements :

Education : HS Diploma Min. and 4 years of exp.

Associate's Degree : 3 years of exp.

BS Degree : 1+ years of exp.

Knowledge, Skills and Abilities

Excellent oral and written communication skills demonstrated by communicating with

other functions and management regarding resolving testing, investigations and theory

Strong data-analysis skills, with clear demonstrated understanding of analytical,

troubleshooting and problem solving skills.

Proven math skills

• Hands on experience in a laboratory X
• Accurate and precise manual pipetting and measuring techniques X
• Demonstrated attention to detail and strong organizational skills X
• Ability to utilize electronic office suite of computer programs X
• Proven ability to meet deadlines and work under aggressive timelines X
• Demonstrated ability to work effectively in a team environment X
• Experience working in GLP, cGMP or ISO regulated environment X
• Experience with 6S and Lean techniques X
• Experience with handling corrosive and biohazardous reagents

Work is performed in a laboratory environment X

Responsibilities :

Performs setup, execution and monitoring of Sequencing process for the Quality Control release of cartridge assemblies.

Prepares sequencing platform equipment, test equipment and materials as required per procedure

Conduct data analysis of test results and determine Quality acceptability per approved procedures

Responsible for generating compliant QC documentation as part of the Device History Record, observations, test results and reports required for releasing items into inventory from the raw material to the in-process finished goods and final products.

Perform a variety of QC duties relating to production manufacturing, including incoming and in-process QC inspections

Maintain records and QC lab environment to comply with cGMP, OP and regulatory requirements

Support 6S effort and continuous improvement to streamline overall operations and improve efficiency Assist in performing maintenance of laboratory equipment

Assist in regular laboratory and manufacturing environmental monitoring testing

Assist in reagent and lab supply ordering and inventory management in order to support the QC laboratory

Ensures equipment is in compliance with calibration standards

Foster and follow an established safety culture, environmental guidelines and procedures for all work performed

May assist with troubleshooting and investigation of QC failures by working with others

May assist in transferring processes from development to QC

May assist in testing raw materials for reliability and stability

May assist in process monitoring and trending

May assist in collecting, interpreting and communicating process metrics for recommended improvements

May assist in performing, reviewing and / or generating validations for QC processes and laboratory equipment

Other duties as assigned

Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Company Description

NESCO Resource Company Overview

Established in 1956, NESCO Resource employs over 10,000 people in 42 states and services a variety of local accounts as well as major accounts. Within NESCO Resource, we have three operating groups with the capability to staff effectively any positions that require Technology, Accounting & Finance, and Clerical & Light Industrial expertise. Rather than the generalist approach most employment agencies pursue, we practice the approach of a specialized staffing firm. We believe our outstanding local growth can be directly attributed to the credibility of our employees and their ability to focus on the specific needs of our customers.

Nesco Resource is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.

Company Description

NESCO Resource Company Overview\r\nEstablished in 1956, NESCO Resource employs over 10,000 people in 42 states and services a variety of local accounts as well as major accounts. Within NESCO Resource, we have three operating groups with the capability to staff effectively any positions that require Technology, Accounting & Finance, and Clerical & Light Industrial expertise. Rather than the generalist approach most employment agencies pursue, we practice the approach of a specialized staffing firm. We believe our outstanding local growth can be directly attributed to the credibility of our employees and their ability to focus on the specific needs of our customers.\r\n\r\nNesco Resource is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.