Senior Validation & Compliance Analyst

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job Details

Job Summary: 

The individual conducts a compliant validation process for systems which require formal validation documentation (including standard operating procedures) under appropriate federal regulations. Coordinates activities with clients and programmers/developers. Identifies current requirements and assures compliance according to the appropriate regulations which govern the user's applications. Keeps abreast of changing regulatory requirements and the availability of current techniques. This role is responsible for analyzing, drafting, designing, and executing validation strategies and developing protocols.

Essential Duties: 

• Provide quality and regulatory guidance for customer BECS validation processes and deliverables.

• Assess whether validation documentation meets regulatory expectations for completeness, accuracy, traceability, and data integrity.

• Compile and analyze validation data, prepare reports and develop solutions for changes and/or improvements.

• Demonstrate commitment to the quality policy.

• Document work methods and procedures.

• Identify and develop new Validation Service offerings, and/or assist in the revision and enhancement of validation programs to accomplish corporate objectives.

• Revision development of validation documentation within each new software release.

• Creates and executes validation planning for projects of moderate to large scope and complexity and revises as appropriate to meet changing needs and requirements.

• Identify, troubleshoot, document and report defects according to procedure.

• Organize and maintain library of validation documentation, scripts and other files.

• Oversee validation tasks and resources that result in timely deployment of validation services within project timeline. Assist clients during on-site validation activities if needed.

• Provide mentoring to other team members.

• Remains abreast of developments in the field of manufacturing, computer technology, blood banking, quality and validation, as applicable.

• Schedule, plan and lead multiple projects, including the delivery of validation services and materials to clients and day to day oversight of validation activities.

• Track and communicate validation status to clients, project manager and management.

• Work closely with clients to measure the effectiveness of the validation programs.

• Provide support in the management of product and process improvement initiatives that directly benefit the customer.

Qualifications/Education

• Bachelor's Degree - Required

• ASQ CQIA - Preferred

Experience Requirements

• 4-6 years Experience in Quality Assurance, Regulatory Affairs, or Validation within a regulated industry (plasma, biotech, medical device, pharmaceutical, or clinical laboratory). Required

• Strong understanding of FDA, GHA, PPTA, CLIA, and other relevant regulatory frameworks. Required

• Demonstrated experience reviewing validation documentation for external audits. Required

• Deep knowledge of 21 CFR Part 11, data integrity principles, and electronic records/e‑signature requirements. Required

• Experience with multi‑system workflows (e.g., donor management systems, LIMS, lab instruments, middleware). Required

• Experience with plasma‑center systems (e.g., donor eligibility, sample tracking, NAT/VMT workflows). Required

• Prior experience as an auditor or in supporting FDA/GHA/PPTA inspections. Required

• Familiarity with validation automation platforms (ACCELQ, Selenium frameworks, custom automation tools). Preferred

• Experience with NexLynk DMS. Preferred

Skills

• Demonstrated analytical and time management skills

• Excellent interpersonal skills and ability to work well with team members and/or customers at various levels

• Works independently with minimal supervision coupled with ability to work in a collaborative environment with cross-functional teams

• Proficiency in Microsoft Office products (including MS Project) preferred

• Exceptional attention to detail and ability to identify subtle documentation gaps or compliance risks.

• Strong written and verbal communication skills and listening skills

Pay Transparency:

The pay range for this role is:

EEO Policy Statement

The base pay actually offered to the successful candidate will take into account, without limitation, the candidate’s location, education, job-knowledge, skills, and experience in prior relevant roles.

Incentives may also be provided as part of Haemonetics’ employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company’s long-term incentive plan, with eligibility and target amount dependent on the role.

In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, “flexible time off” for salaried employees and, for hourly employees, accrual of three to five weeks’ vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits.

Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact 1-781-348-7777, Monday through Friday, 7:30 a.m. – 5 p.m. ET or email AskHR@Haemonetics.com.