QA Engineer I
Kelly Services is seeking a Quality Assurance Engineer I for one of our top clients in the Austin, Texas area. The Quality Assurance Engineer is responsible for working in the Quality Assurance department and assisting with maintaining compliance to the overall Corporate Pharmaceutical Quality Systems. Specific job duties will include assisting and/or performing activities associated with the pharmaceutical Quality Assurance processes.
Responsibilities:
Assist with the Vendor Qualification System, including interactions with vendors to facilitate the completion of vendor surveys, perform risk analysis, audit, and write audit reports.
Assists with internal audits and the audit of vendors, as required by internal procedures, includes coordination of travel, audit, and providing audit reports to the vendor.
Performs controlled substance inventory activities which include: ordering (DEA 222 forms); receiving, logging, and issuing controlled substances for laboratory testing; maintaining, auditing and reviewing logbooks; other activities as directed.
Support the Product Complaint process including fiending the intake, processing, investigating, and trending of complaints. This includes speaking with patients and timely follow-up with vendors, physicians, pharmacists, and other applicable stakeholders as needed.
Maintain the Product Complaint database including trending of all complaints and ensuring appropriate information is provided to senior management.
Route manufacturing and quality documentation to vendors and Benuvia management for consensus and approval.
Issue, review, and approval of Change Controls (CCs) related to all controlled documents.
File and maintain records (manual or electronic) in accordance with established policies, procedures and regulatory requirements, Including Change Control and QA
Perform QA document review on Manufacturing and Quality documents.
Establishes training for other departments, works independently to contact and train employees in other departments.
Writes, reviews, and revises SOPs, Protocols, and other company documents as required from supervisor.
Requirements:
Bachelor of Science in Chemistry or related field; Life Science degree preferred
At least 3 years of related experience in the pharmaceutical/medical device industry (commercial environment)
Experience with administration and use of electronic QMS systems (i.e. MasterControl)
General knowledge of pharmaceutical/device auditing experience required (internal and external auditing), CQA or other quality auditing certification highly desired
Intermediate level of GMP knowledge; Familiarity with GCP regulations; Knowledge and experience of the current requirements of FDA and ICH Guidelines along with hand-on experience managing regulatory inspections
Why Kelly ® ?
Kelly® Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
About Kelly ®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm