Quality Engineer

CBR Englewood , CO 80110

Posted 6 months ago

The role of the Quality Engineer is to provide quality oversight to the warehouse, production and laboratory areas and staff. The Quality Engineer will identify and address product quality and compliance related issues. During company start up, the role will also include design and implementation of quality systems. The successful candidate will have the willingness and agility to transition successfully when priorities and responsibilities change.

STAQ Pharma is a new 503B Outsourcing facility located in Denver, CO. STAQ draws upon a rich legacy of innovation and a robust pipeline of promising medicines to help people. In addition to developing a strong portfolio of medicines for pediatric patients, STAQ has built an 18,500 sft facility with robotic automation to become the leading 503B outsourcing facility in the country, serving the needs of pediatric and adult populations. Learn more at www.staqpharma.com.

Responsibilities

  • Provides day-to-day QA oversight of warehouse, production, and laboratory operations.
  • Manages document control and training processes.
  • Participates in the purchase, install, qualification / validation of manufacturing and laboratory equipment.
  • Authors, reviews, and approves procedures to meet and maintain cGMP, USP, and state (intra commerce and distribution) requirements.
  • Reviews production batch records to ensure adherence to company policies, procedures and cGMP requirements.
  • Leads / participates in root cause analysis for event resolution and CAPA identification.
  • Collaborates cross-functionally to implement continuous improvement.

Requirements

  • Bachelors degree (or equivalent experience)
  • 4+ years of relevant GMP work experience in the pharmaceutical, biotechnology, or medical device industry. 2+ years of QA experience preferred.
  • CQA or CQE preferred
  • Must be a team player and effectively collaborate with internal department.
  • Excellent technical writing skills and attention to detail.
  • Demonstrates ability to gather and evaluate relevant information and make independentdecisions.
  • Knowledge of and proficiency in the use of basic statistics.

Benefits

Salary: $75,000-$90,000 annually, depending on experience.

Staq Pharma offers an excellent benefits package including medical with a generous employer contribution, dental, vision, LTD, STD, Life, 401(k), Paid Time Off and Holiday pay.

Staq Pharma is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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