JOB SUMMARY

The Laboratory Quality Assurance (QA) specialist, along with the Quality team, is responsible for the execution and maintenance of systems supporting quality, laboratory, and operational initiatives. This includes document management and review, quality metrics, training, internal assessments, and the execution of lab methods. The Lab QA Specialist will be responsible for direct support of site quality units as required by our programs and/or of the corporate quality team.

DURING A TYPICAL DAY

• Serve as a champion and resource for quality assurance needs as defined by location and program.
• Lead local document control efforts as required by quality programs. This includes document issuance, release, and review as required.
• Manage and troubleshoot situations relating to quality systems, training, and documentation.
• Drive efficiency improvements around quality systems, tools, and requirements.
• Support laboratory improvements and systems to drive data integrity, SOP improvement, and documentation compliance.
• Execute laboratory tests following established SOPs.
• Support strategic execution of tools and systems to maintain documentation and records compliance requirements (21 CFR part 11, etc.).
• Prioritize your schedule in order to engage in cross-functional activities to support the business.
• Interface with the corporate quality team on system optimization, access, and continuous improvement.
• Support and train POET team members on Quality policies and expectations.
• Ensure accountability to good documentation practices within POET.
• Facilitate communication between departments within POET and POET Bioprocessing locations to maintain an effective teamwork environment.
• Stay acquainted with quality-facing programs, processes, and environments within POET and potential 3rd party partners.
• Support local Quality Metrics to facilitate quality-driven continuous improvement.
• Support Deviation/CAPA resolution as needed.
• Support and coordinate bioprocessing Quality Unit onboarding and training as required.
• Develop and provide technical presentations to relating to Quality initiatives.
• Foster a culture of safe behavior and regulatory compliance at all times.
• Maintain a team environment at all times and champion POET in the community.

STRENGTHS OF A SUCCESSFUL CANDIDATE

• Bachelor’s degree or greater in scientific field, Biology and Chemistry preferred.
• 2 or more years of people, project, or program management experience.
• 2 years’ experience with Quality programs, certification structures, system and program deployments, and FDA regulated environments.
• 2 or more years of experience in a laboratory environment with an understanding of common analytical laboratory instrumentation (chromatography, spectroscopy, etc.).
• Experience in an operating plant environment such as grain processing, food processing, or chemical processing is preferred.
• Excellent organizational, time management, and communication skills as well as the ability to embrace change.
• You know the basics of Microsoft Office Suite. You’re capable of learning new programs.

GROWTH OPPORTUNITIES WITHIN POET

At POET we believe in developing our team members to their highest potential and recognizing contributions that add value to the organization. Each new team member’s position and compensation are carefully determined by considering their unique qualifications and skillset.

WORK ENVIRONMENT

• Culture is king at POET. We’re all on the same team. We always communicate. And we park our egos at the door. These aren’t just slogans on our walls. It’s the way we do things at POET.
• In this role, you’ll be asked to drive a POET vehicle. A motor vehicle record check will be conducted during the preemployment process and yearly thereafter.
• The work environment at POET is dynamic. You should expect a balance between time spent in the office and at the bioprocessing facility, which may include some physical labor helping your team members.

POET is an Equal Opportunity Employer (EOE). POET complies with all applicable federal, state and local laws regarding hiring and employment. Qualified applicants are considered for employment without regard to age, race, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.