Quality Control Laboratory Technician II (Contract)

Quality Control Technician II directly supports Operations by performing inspections and testing for quality assurance. The Technician contributes and adheres to all QC processes and procedures. Daily activities for this role include material inspections high complexity testing equipment maintenance and troubleshooting interfacing with service providers process monitoring executing quality control assays environmental monitoring and preparing quality documentation. This role is routinely involved in executing tests and reporting results for inspections validations verifications and investigations. The individual will demonstrate excellence by representing Quality Control in supporting key processes.

Essential Functions & Accountabilities:

• Adhere to corporate and Quality Control policies
• Ensure all work performed strictly adheres to cGLP/cGMP
• Exercise Good Documentation Practices (GDP)
• Use company Quality Management System (QMS) Laboratory Information System (LIS) equipment management software environmental monitoring software
• Accurately complete and maintain records that meet regulatory requirements
• Perform quality control testing and inspections
• Perform material inspection and release activities
• Coordinate and perform equipment calibration preventive maintenance and repairs
• Perform inprocess monitoring and data trending
• Perform equipment Installation Operation and Performance Qualifications (IQ/OQ/PQ)
• Perform environmental monitoring (EM) activities
• Respond to environmental monitoring alarms
• Prepare reports and certificates for tests and inspections
• Follow the laboratorys established policies and procedures whenever test systems are not within the laboratorys established acceptable levels of performance
• Notify management of deviations and initiate deviation/nonconformance process in the applicable quality system
• Assist with lab investigations deviations corrective actions change control method qualification planning etc.
• Provide audit preparation support activities
• Provide administrative support:copying filing and archiving records
• Support the everyday organization of laboratory activities including area cleaning maintenance and ordering of supplies
• Work in a biosafety level2 (BSL2) work environment
• Wear appropriate Personal Protective Equipment (PPE)
• Follow the laboratorys procedures for specimen handling and processing reagent preparation test analyses reporting and maintaining records
• Train and maintain competence on a broad range of laboratory support functions and procedures as assigned demonstrating expertise in technical skills and procedures within the assigned discipline area(s) including analytical bioanalytical and microbiological responsibilities
• Coordinate proficiency testing and participate in competency assessments.
• Provide support during peer training
• Participate in training projects housekeeping and other related activities
• Support Research and Development projects
• Support method development qualifications and validations
• Support material purchase ordering activities
• Support inventory monitoring and control activities
• Prioritize and organize work to deliver assignments according to established schedules and deadlines
• Communicate in a manner that fosters cooperation and creates a safe environment for those involved
• Familiarity with basic statistical tools to analyze data in relation to trends results
• Capable of routinely multitasking
• Problem solving and troubleshooting competencies
• Make informed and timely decisions independently
• Maintain confidentiality
• Apply common sense understanding to carry out instructions furnished in written oral or diagram form.
• Apply common sense understanding when working independently on departmental projects timelines and dealing with compliance issues.
• Excellent communication skills with the ability to collaborate effectively with teams across all departments
• Performs other tasks as assigned by management

Additional Responsibilities:

• Capable of working with a moderate degree of supervision and organizing own time
• Support documentation generation and revisions (SOPs work instructions forms protocols reports etc.)
• Support compliance procedures and policies (ex.: training incident reports deviations documentation)
• Draft IQ/OQ/PQ protocols and summary reports
• Draft and edit Standard Operating Procedures (SOPs) Work Instructions and Forms
• Execute formal raw data review activities
• Represent Quality Control on crossfunctional projects

Travel:

• 010% Travel

Knowledge Skills and Abilities:

• To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below 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.
  • Language Skills: Ability to read and interpret documents such as safety rules operating and maintenance instructions and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of employees of organization. Must be proficient in written and spoken English.
  • Mathematical Skills: Ability to add subtract multiply and divide in all units of measure using whole numbers common fractions and decimals. Ability to compute rate ratio and percent and to draw and interpret bar graphs.
  • Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written oral or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
  • Computer Skills: Requires complete and broad knowledge of operating systems techniques and practices typically learned through experience and/or education. Must be able to utilize analytical instrument and enterprise resource planning software. Must be proficient in Microsoft applications: Excel Word PowerPoint Outlook.
  • Physical Demands: 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. While performing the duties of this job the employee is regularly required to stand for extended periods; use hands to finger handle or feel and talk or hear. The employee is frequently required to walk; sit and reach with hands and arms. The employee is occasionally required to stoop and kneel. The employee must frequently lift and/or move up to 50 pounds. On occasion employee must frequently lift and/or move up to 100 pounds with assistance. Specific vision abilities required by this job include close vision distance vision and ability to adjust focus.
  • Teamwork: Leads by example to maintain positive attitude and collegial work environment. Provides and is receptive to constructive feedback. Assist other team members as needed to accomplish the days or department tasks.

Work Environment:

• Schedule/ Work Hour Requirement:
  • This is an onsite position
• Exposure Risk:
  • A requirement of this role is working with blood products and tissue. Safeguards are implemented for employees to protect them from exposure to blood products and tissue.

Clinical Laboratory Improvement Amendments (CLIA) Responsibilities and Qualifications:

• This role requires to take on additional roles to perform High Complexity testing (example: Testing Personnel General Supervisor) and/or perform additional functions (example: high complexity testing) that are regulated by Clinical Laboratory Improvement Amendments (CLIA). In such cases the Laboratory Director and General Supervisor shall determine eligibility based on additional requirements such as: Internal company and CLIA baseline educational training and experience.

Experience:

• Internal candidates must fully satisfy the requirements of the Technician I Quality Control role or relevant Technician role to be considered eligible for the Technician II Quality Control role.
• Previous experience in a laboratory medical device or pharmaceutical environment is preferred.
• Familiarity with industry standards and certifications (ISO 9001 ISO 17025 ISO 13485 etc.).
• Proficiency with quality management software and statistical analysis tools.
• Strong problemsolving and root cause analysis skills.

Education:

• Have a degree in Bachelors degree in in a Biological Chemical Physical Science or related field and 13 years of work experience in a GxP laboratory experience. OR
• Minimum of 35 years of relevant laboratory work experience