QA Incoming Inspection Inspector I (3rd Shift) at 6270 GenMark Diagnostics, Inc. in Carlsbad, California

Job Description:

The Position

This position is responsible for performing inspection and/or verifications of incoming materials, parts, and final container assemblies used in the manufacture of GenMark products.  In addition, candidate must ensure materials meet specifications as identified in the quality inspection acceptance criteria. The candidate interfaces with various departments including quality assurance, quality control, product technical support, warehouse, and production personnel to: (1) ensure sufficient inventory for production needs and (2) resolve any associated quality issues that arise from product inspection.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Responsible for day-to-day receiving inspection of all incoming materials following quality control compliance procedures.




• Ensure that final finished products assembled in the production area meet all required quality control requirements as stipulated in either the assembly work instructions or final inspection procedures.




• Accurately documents the results of the verifications and complies with Good Documentation Practices.




• Reports inconsistencies observed during quality inspections for product or material verification to shift lead.




• Maintain all controlled document files and verification records in a timely and accurate manner.




• Ensures calibration and preventative maintenance records for inspection equipment are current.




• Must be able to lift up to 50 pounds on an occasional basis.




• Must be willing and able to work weekday, weekend and mandatory overtime hours as required to meet the production demands of the team.




• Able to work independently, also balances team and individual responsibilities, exhibits objectivity and openness to others’ views, gives and welcomes feedback, contributes to building a positive team spirit, able to build group commitments to goals and objectives, supports team efforts.




• Detail oriented, is accurate and delivers quality work, looks for ways to improve and promote quality, demonstrates accuracy and thoroughness, applies feedback to improve performance, monitors own work to ensure quality and Sense of urgency.

POSITION REQUIREMENTS

Education and Experience 

• Minimum HS diploma or GED is required and 2+ years Quality Control experience in Receiving Inspection is preferred or 1-year experience in ePlex manufacturing line.




• Electronic PCB (printed circuit board) inspection experience is preferred.

Skills – Technical

• Familiar with AQL Sampling, reduced inspections, tightened inspections and switching rules.




• Experience performing inspections on mechanical, electrical, and optical components and assemblies.




• Experience in reading and interpreting mechanical drawings and specifications.




• Experience with inspections of returned materials (RMA’s), and repaired materials returned from vendors.




• Proven ability to prioritize responsibilities in a high pressure, dynamic, multi-tasking environment.




• Experience working in an FDA regulated environment is preferable.




• Experience using a PC and Microsoft Word and Excel.

Skills – General

• Must be a hands-on, self-directed, detail oriented and conscientious individual




• Complete work in a timely, accurate and thorough manner.




• Must be able to think and work both tactically and strategically to provide financial and operational needs to GenMark’s business.




• Effective analytical problem solving, judgment and decision-making skills are required.




• Strong time management and organizational skills in a dynamic, constantly changing environment.




• Ability to read, write and analyze complex documents.




• Ability to respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, peers and individuals.




• Ability to work effectively, exhibit a professional manner and establish constructive working relationships.

WORK ENVIRONMENT

The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate.  This position may involve a combination of office and biotechnology laboratory environments.   The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment.

While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear.  The employee is frequently required to stand and walk.  The employee may sometimes be required to lift and/or move up to 35 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.

*Relocation assistance is NOT available for this role*

The expected salary range for this position based on the primary location of California is $34,700.00 to $64,400.00.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

Who we are

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare.  As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses.  GenMark’s ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.