Quality Engineer Support

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Job Responsibilities

• Provide Quality Assurance oversight for the execution, commissioning, qualification, and validation activities for major projects.
• This may include, but is not limited to; Factory Acceptance Testing, construction oversight, execution of onsite commissioning and qualification activities, support for process validation, etc.
• Ensure execution of capital projects consider USDA and EMA regulatory and quality requirements.
• Review relevant documentation including user requirement specifications, design specifications, DQ, SAT, FAT, IQ, OQ, PQ documents, PFDs, validation plans / protocols, etc.
• Escalate protocol departures of critical nature and ensure issues are addressed and remediated accordingly
• Provide technical consultation and interpretation local procedures, corporate standards and regulatory expectations.
• Demonstrate strict adherence to relevant local, state and federal requirements, cGMP standards and client policies and procedures.
• Exemplify “Safety First and Quality Always” mind-set.

Requirements

• Bachelor's of Science degree in Engineering or related fields
• 3+ years supporting cGMP manufacturing? Additional Skills Preferences
• Prior experience in C&Q, CQV and/or CSV
• Proficient with computer systems including Microsoft office and electronic document management systems (Veeva)
• Ability to organize and prioritize multiple tasks and to problem solve effectively
• Ability to work under time pressure and exert good judgement in special situations
• Strong communication and interpersonal skills
• Excellent technical writing skills.
• Working knowledge of VICH, USDA and/or EU GMP regulations for veterinary biologics.

Up to 1 year contract opportunity; onsite in Kansas.