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Quality Assurance Associate - Panaceutics

The Launch Place Danville, VA
  • Expired: over a month ago. Applications are no longer accepted.

About Panaceutics

The new era of personalized healthcare is built on a foundation of on-demand formulation, which enables B2B stakeholders, such as healthcare systems, integrated delivery partners, pharmaceutical companies, and nutritional product manufacturers to provide personalized pharmaceutical poly therapies and clinical nutrition products to high volume populations – fast, safely, accurately, and efficiently – with enhanced CGMP compliance and without the need for costly in-house infrastructure and associated overhead.

Formulation With over 100 years of combined expertise in specialty medications and pharmacies, cloud computing, and robotics technologies, Panaceutics has started a revolution in next generation precision poly therapy dosing and delivery. Panaceutics is focused on automating production of personalized healthcare solutions under CGMP manufacturing standards.

Through our innovative cloud-based, robot-automated, high-throughput system, Panaceutics quickly develops individual formulations using high- quality generic medications based on an individual’s personal clinical and genomic profile for safer, more effective drug combinations.

https://panaceutics.com

About Position

Reporting to the Quality Director, the Quality Assurance Associate is responsible for ensuring compliance with Current Good Manufacturing Practices (CGMP) and Good Documentation Practices (GDP). In addition, s/he will be responsible for ensuring efficient and effective operational functionality of product by performing a number of quality control processes, including, but not limited to: conducting quality audits to ensure product quality; ensuring that employees adhere to manufacturing, hygiene and sanitation standards. The person in this position will implement, execute, and enforce procedures by way of systems that will improve the overall operations and effectiveness of the company by way of regulatory compliance. Supporting production staff in problem solving efforts. Following up and participation in continuous improvement projects.

Required Experience:

  • 0–2 years of CGMP experience in an FDA regulated industry.
  • Experience in a CGMP environment is strongly preferred.
  • Demonstrates strong interpersonal and communication skills (both written and oral), a strong customer focus, and ability to interact with various departments and levels.
  • Demonstrates ability to work independently and as part of a team, to meet department/facility goals; is also able to work across functions to achieve commons goals.
  • Demonstrates strong attention to detail, and an ability to focus on detail of execution.
  • Demonstrated ability to multitask and meet deadlines.

Working Location: RTP, North Carolina, Danville, Virginia

Required Education: Bachelors in a scientific discipline.

Job Description:

  • Conduct in-process and final product testing following Standard Operating Procedures.
  • Responsible for assuring that products are tested to meet the highest quality standards as determined by performance specifications.
  • Adheres to GDP to ensure data integrity and traceability.
  • Effectively implement and maintain the company’s standard operating procedures (SOPs).
  • Understand test results and pursues clarification of out of specification (OOS) or out of trend (OOT) results.
  • Responsible for ensuring that QC tasks are completed timely according to: schedule, company policies, procedures and test methods.
  • Responsible for assuring that products are tested to meet the highest quality standards as determined by performance specifications.
  • Perform pre-operation inspection at the beginning of the production shift as well as pre-sanitation inspection at the end of the shift.
  • Perform environmental monitoring (EM) of the production and testing areas.

Key Responsibilities:

  • Check HACCP critical control points and ensure proper corrective and preventive actions (CAPA) are taken to maintain food safety.
  • Pre-op inspection of the processing line according to established procedures.
  • Inspect incoming raw materials and packaging.
  • Pull random samples and test raw materials to make sure they meet specifications.
  • Assist and/or provide authorization of batch disposition and product shipments.
  • Issue Batch Production Records per schedule.
  • Collect appropriate samples of finished products and raw materials for testing.
  • Provide QA review of GMP documentation, including material specifications, SOPs, production records, validation protocols, and validation reports.

Essential Skills:

  • Must be able to wear company specified garments that assure cleanliness.
  • Ability to work independently and as part of a team, to meet department/facility goals; is also able to work across functions to achieve common goals.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

The Launch Place

Some jobs posted are for The Launch Place portfolio companies - http://www.thelaunchplace.org/portfolio-companies The Launch Place is an independent 501(c) (3) organization that energizes and diversifies our regional economy through entrepreneurship development and business consulting services. Headquartered in Danville, VA, and a branch office in the Research Triangle Park, NC has been in existence since 2005. The Launch Place works with entrepreneurs who want to start and/or grow their business. We offer a full range of services, from business consulting, training, office space to funding, all of which are designed to give entrepreneurs the tools they need to navigate the challenging start-up stages and successfully launch their company. The Launch Place also invests in start-up companies through The Launch Place Fund and The Launch Place Pre-Seed Fund. The Launch Place also offers consulting services to local and regional private businesses, economic development organizations, non-profit institutions and local governments and in so doing contributes to the economic transformation of the Dan River region of Virginia and North Carolina. It has a proven track record in helping businesses to grow and remain competitive both domestically and in global markets.

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Danville, VA
USA

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