Senior Quality Assurance (QA) Consultant

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.

Senior Quality Assurance (QA) Consultant

Location: Remote (U.S.)

About Valspec

Valspec is a leading provider of engineering, validation, quality, and compliance consulting services to the life sciences industry. We partner with pharmaceutical and biotechnology organizations to support critical quality, regulatory, and operational initiatives. Our consultants are trusted technical experts who help clients maintain compliance while driving business continuity and operational excellence.

Position Summary

Valspec is seeking an experienced Senior Quality Assurance (QA) Consultant to support a pharmaceutical client through a critical quality systems engagement. This consultant will serve as a key member of the Quality organization, providing review and approval support for quality records while ensuring compliance with GMP requirements and internal quality procedures.

The successful candidate will have extensive experience working within electronic Quality Management Systems (eQMS), with particular emphasis on complaint management, deviation review, change control approval, and quality record oversight. This individual must be comfortable working independently in a fast-paced environment while partnering with Quality, Manufacturing, Technical Operations, and Regulatory stakeholders.

This is a remote consulting opportunity with an initial anticipated duration of approximately eight weeks, with potential for extension based on business needs.

Responsibilities

• Review and approve quality system records in accordance with GMP regulations and company procedures.
• Serve as a Quality Assurance approver for:
  • Product Complaints
  • Deviations
  • Change Controls
  • Quality Records
• Ensure quality documentation is complete, accurate, and compliant prior to final approval.
• Review investigations and supporting documentation for technical adequacy and regulatory compliance.
• Evaluate proposed changes for product quality, compliance, and business impact.
• Support timely closure of quality events and quality system records.
• Collaborate with cross-functional teams to resolve quality issues and maintain compliance expectations.
• Provide guidance on quality system processes, documentation requirements, and approval workflows.
• Utilize Veeva Quality Systems to review, manage, and approve quality records.
• Support generation and analysis of quality metrics and reports as project needs require.
• Participate in quality review meetings and contribute to continuous improvement initiatives.
• Assist with inspection readiness and audit support activities as needed.

Required Qualifications

• Bachelor's degree in Life Sciences, Engineering, Chemistry, Microbiology, or related technical discipline.
• 8+ years of Quality Assurance experience within pharmaceutical, biotechnology, or regulated manufacturing environments.
• Demonstrated experience reviewing and approving:
  • Product Complaints
  • Deviations
  • Change Controls
  • Quality Records
• Hands-on experience working within Veeva Quality systems.
• Strong understanding of cGMP regulations and quality system requirements.
• Experience conducting quality record assessments, investigations, and risk evaluations.
• Ability to independently manage a high volume of quality system activities.
• Excellent technical writing, documentation review, and communication skills.
• Proven ability to work effectively with cross-functional stakeholders in a remote environment.

Preferred Qualifications

• Previous experience serving as a Quality Systems approver within a pharmaceutical manufacturing organization.
• Experience developing, monitoring, or reporting quality metrics and performance indicators.
• Experience supporting regulatory inspections and audit readiness initiatives.
• Familiarity with TrackWise and other electronic Quality Management Systems (eQMS).
• Consulting experience supporting multiple client organizations.

Key Competencies

• Quality Systems Leadership
• Complaint Management
• Deviation Management
• Change Control Review & Approval
• Veeva Quality Systems
• GMP Compliance
• Risk Assessment
• Investigation Review
• Quality Metrics & Reporting
• Cross-Functional Collaboration

Why Join Valspec?

This opportunity allows an experienced quality professional to make an immediate impact by supporting a critical business function within a highly regulated pharmaceutical environment. The consultant will work closely with quality leadership while helping ensure compliance, business continuity, and efficient execution of key quality system processes.

Join a great team supporting leading life sciences organizations. Apply today!

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.