QA Consultant

QA Consultant Valspec - 4.6 San Francisco, CA Job Details 16 hours ago Benefits Health insurance Tuition reimbursement 401(k) matching Employee stock ownership plan Qualifications Quality control corrective actions Computer science Industrial automation Document review (document control) GAMP Human-machine interface (HMI) systems Computer Science Pharmaceutical regulatory compliance Engineering Corrective and preventive actions (CAPA) Mid-level 3 years Programmable logic controllers Bachelor's degree in engineering Continuous improvement Pharmaceutical plant experience Supervisory control and data acquisition (SCADA) Industrial equipment Quality assurance within manufacturing Manufacturing Commissioning phase involvement Cross-functional collaboration Bachelor's degree in computer science Communication skills Cross-functional communication FDA regulations Engineering validation Full Job Description Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals. Valspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

Automation QA Engineer Location:

Remote Employment Type:

Contract / Consulting (6-12+ months)

Start Date:

ASAP About the

Role:

We are seeking experienced Automation QA Engineers to support our clients in North Carolina. These roles will support automation quality assurance activities within a GMP-regulated pharmaceutical manufacturing environment, with a strong focus on commissioning, qualification, validation, and lifecycle documentation for automation systems. This is an excellent opportunity for candidates with pharmaceutical or biotech automation QA experience who are comfortable working cross-functionally with Validation, Engineering, Manufacturing, and Quality teams in support of large-scale capital and operational projects. Key Responsibilities Provide QA oversight and support for automation-related qualification and validation activities Review and approve validation lifecycle documentation including:

IQ/OQ/PQ

protocols and reports Risk assessments Traceability matrices Change controls Deviations and CAPAs Support automation systems operating within GMP manufacturing environments Ensure compliance with FDA, c

GMP, GAMP

5, and 21 CFR Part 11 requirements Partner with Automation, CQV, CSV, Manufacturing, and Quality teams to ensure compliant execution of project deliverables Participate in document reviews, project meetings, and quality assessments Support audit readiness and inspection preparedness activities Assist with implementation and continuous improvement of validation and QA processes Preferred Systems / Technologies Experience with one or more of the following is highly preferred: DeltaV Rockwell / PLC systems SCADA or HMI platforms MES systems (Syncade experience is a plus) Historian systems Automated manufacturing equipment within pharma/biotech environments Qualifications Bachelor's degree in Engineering, Life Sciences, Computer Science, or related field preferred 3+ years of experience in Automation QA, CSV, CQV, or Validation within the pharmaceutical, biotech, or regulated manufacturing industry Strong understanding of GMP compliance and validation lifecycle principles Experience reviewing and approving GMP documentation Familiarity with data integrity and 21 CFR Part 11 requirements Excellent communication and cross-functional collaboration skills Ability to work independently in a remote environment Why Join Valspec? At Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership. As an Employee Stock Ownership Plan (ESOP) company, every team member has a stake in our success, fostering a shared commitment to excellence and innovation. We also offer a highly competitive benefits package, including: Premium medical coverage 401(k) with company match Tuition reimbursement Unique performance incentives And more — all designed to support your growth, well-being, and future. Join a team where your contributions matter, your development is prioritized, and your success is shared. When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net. Any other domains are impersonations and should be ignored. Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time. Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established. Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.