QUALITY ASSURANCE SUPERVISOR

PBL has an immediate opening for a Quality Assurance Supervisor. The primary duty of the Quality Assurance Supervisor is ensuring regulatory compliance is met via data review and inspection of testing activities. The Quality Assurance Supervisor operates in a team environment and consequently must perform activities with diplomacy and tact. The Quality Assurance Supervisor role presents the employee with an opportunity to both learn the skills required to advance in the field of quality assurance and play a crucial role in the company’s long-term success.

RESPONSIBILITIES FOR THE QUALITY ASSURANCE SUPERVISOR INCLUDE BUT ARE NOT LIMITED TO

  • Ensure regulatory compliance is met and internal PBL SOPs, methods, protocols and study plans are followed
  • Schedule, perform, and review internal audits, investigations, inspections and assessments
  • Perform and/or oversee quality support activities including equipment management, login/receiving, document control, and archiving
  • Provide personalized, proactive, friendly, and responsive services to internal and external clients
  • Guide Study Directors and Analysts in meeting regulatory requirements
  • Participate in quality improvement projects
  • Lead and/or assist in conducting and hosting client and regulatory audits as well as audit response
  • Respond to client requests for information pertaining to regulatory issues, guidelines and testing information in a prompt, efficient manner that cultivates trust and reliability
  • Assist processing of client dissatisfactions
  • Ensure QA review throughput meets requirements for quality and turnaround time
  • Manage the daily schedule and distribution of work in the QA team
  • Manage training of QA team
  • Monitor and trend output of the QA team and implement measures to continuously improve performance of the team
  • Provide input to Management regarding performance of QA team

TECHNICAL RESPONSIBILITIES

  • Lead QA staff in the review of raw data, electronic audit trails, results and reports
  • Lead QA in processing corrected, amended and/or reissued reports
  • Review and approve equipment qualifications, calibrations, and maintenance records
  • Initiate and lead investigations for deviations, out-of-specification, and corrective/preventive actions
  • Process, review, and approve change controls
  • Review and approve validation protocols and reports

ADMINISTRATIVE RESPONSIBILITIES

  • Monitor subcontracting of testing to other laboratories
  • Administer review and approval process for company SOPs
  • Supervise QA staff in maintaining the company’s Form Control System
  • Trend data obtained from monitoring quality parameters
  • Comply with GMP/GLP and ISO requirements
  • Demonstrate knowledge of and familiarity with all SOPs

EDUCATION/EXPERIENCE

  • B.S. in Science or Life Science field (or equivalent in training/experience) preferred
  • Minimum 5 years of experience in Quality Assurance or in a regulated industry preferred
  • Minimum 3 years of direct supervisory experience expected
  • Decision making experience of minimum 3 years
  • Thorough knowledge and understanding of FDA Quality regulations required
  • Thorough knowledge and understanding of ISO Quality standards required
  • Quality Auditor certification preferred

ESSENTIAL SKILLS

  • Critical thinking and problem-solving skills
  • Excellent organizational skills and ability to prioritize multiple tasks
  • Ability to obtain and assess objective evidence
  • Proficiency in Microsoft Office

INTER-PERSONAL SKILLS

  • Ability to diplomatically implement oversight of work activities of fellow employees and direct reports
  • Excellent language and communication skills (written and verbal) required
  • Must be able to clearly communicate priorities and responsibilities on a daily basis. Must be able to convey complex ideas in easily understandable terms to both internal staff and outside auditors.
  • Good listening skills essential. Must be able to elicit precise information from persons with varying professional expertise.
  • Solid leadership skills essential. Must be able to lead both by example and through direct authority. Must be able to unite staff under common goals pertaining to compliance. Must be able to build consensus across departments. Must be capable of establishing and maintaining effective peer-to-peer relationships with technical staff and management. Must be able to deliver criticism in a constructive, diplomatic manner.
  • Must be a mentor, capable of managing change and willing to empower followers

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, vision, 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.

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