QUALITY ASSURANCE SPECIALIST  1 and 2

JOB SUMMARY

Employees working as Quality Specialists in the Quality Assurance department report to the Quality Manager or designated person. The primary duty of the Quality Specialist 2 position is data review and inspection of testing activities (toxicology, microbiology, cytotoxicity and analytical chemistry). Other responsibilities include 1) performing investigations, inspections and assessments; 2) performing internal audits; 3) performing and/or overseeing quality support activities related to quality management system implementation (for example, equipment oversight, login/receiving, document control, and archive activities); 4) performing support activities may be required. 5) lead and/or assist in conducting and hosting client audits as well as generating an audit response report. 6) other duties as assigned by Supervisor. The Quality Specialist 2 operates in a team environment and consequently must perform activities with diplomacy and tact. The Quality Specialist 2 presents the employee with an opportunity to both learn the skills required to advance in the field of quality assurance and at the same time play a crucial role in the company’s long-term success.

SERVICE RESPONSIBILITIES TO INTERNAL CUSTOMERS

Quality Specialist 2 will be trained to demonstrate proficiency in the following:

  • Assist Quality Supervisors and Senior Management in administering the company’s Quality Management effort(s)
  • Assist Study Directors and Analysts in meeting regulatory requirements
  • Assist Quality Management in audit planning, performance, follow-up procedures and/or corrective action
  • Ensure that all requests for help, information or support are treated fairly and professionally
  • Assist in trend analysis of the Quality Management System

TECHNICAL RESPONSIBILITIES

Quality Specialist 2 will be trained to demonstrate proficiency in the following:

  • Assist in the review of data generated by technical departments as well as the Final Report/Report of Analysis
  • Performing electronic data and audit trail verification when appropriate
  • Review of equipment qualifications, calibrations, and maintenance records
  • Assist in the review and approval of deviation notices and investigations generated by technical departments
  • Initiate and lead investigations for deviations, out-of-specification, and corrective/preventive actions
  • Assist in the review and approval of unexpected/out of specification notices and investigations generated by technical departments
  • Processing, review, approval of change controls
  • Review of validation protocols and reports
  • Perform review of “complex” report/data packets
  • Assist in processing corrected, amended and/or reissued reports

ADMINISTRATIVE RESPONSIBILITIES

Quality Specialist 2 will be trained to be proficient in the following (at the discretion of management):

  • Assist Quality Management in meeting regulatory requirements (GLP, GMP, QSR, et al.)
  • Oversee the process whereby testing requested by Pacific BioLabs’ clients is subcontracted to other laboratories. Ensure that these laboratories understand our clients’ testing requirements
  • Assist Quality Management in the review and approval process for company SOPs
  • Assist Quality Management in maintaining the company’s Form Control System
  • Compliance with GMP/GLP and ISO requirements
  • Compliance with USP, JP, EP, ICH, OECD, AAMI and/or other guidelines/regulations
  • Knowledge of and familiarity with all SOPs
  • Participation in staff meetings and training sessions

SERVICE RESPONSIBILITIES TO CLIENTS

Quality Specialist 2 will be trained to demonstrate proficiency at the following:

  • Ensure that the company’s system for handling quality complaints is functioning in an efficient and timely manner
  • In regards to testing, ensuring compliance is met both regulatory and via internal PBL SOPs, methods, protocols, study plans and/or other approved written procedures
  • Assist Study Directors and Analysts with providing rapid turnaround time to help clients meet their deadlines
  • Participate in quality improvement projects designed to improve the nature of PBL’s customer service
  • Assist in Client Dissatisfaction investigations
  • Participate in client audit activities
  • Greet Visitors to the lab in a professional, courteous manner
  • Providing, when appropriate, personalized, proactive, friendly and responsive client services

JOB QUALIFICATIONS

  • B.S. in life science field (or equivalent in training/experience) preferred
  • Previous experience in quality assurance or regulated industry 2+ years preferred
  • Decision making role 2+ years

TECHNICAL SKILLS

  • Must be able to think critically; problem-solving skills essential
  • Knowledge of MS Word and MS Excel required
  • Solid organizational skills required; must be able to prioritize multiple tasks
  • Must be able to obtain and assess objective evidence

INTERPERSONAL SKILLS

  • Strong communication skills (written and verbal) required
  • Must be able to communicate complex ideas
  • Ability to diplomatically implement oversight of fellow employees’ work
  • Must be able to work with persons from diverse backgrounds

PHYSICAL ABILITIES

  • Job requires mobile use of hands and arms and ability to lift 30 pounds
  • Job requires mobility through laboratory spaces for auditing purposes
  • Must be capable of working at a desk and computer terminal for up to three hours at a time, and for up to eight hours on a given day
  • Must be capable of sustained concentration over printed materials for several hours at a time

Salary will be commensurate with education and experience. A benefits package including medical, dental and 401(k) is also offered.

Pacific BioLabs is an equal opportunity employer committed to diversity and inclusion. We are pleased to consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other legally protected factors.

Apply for this position via email to Careers@PacificBioLabs.com