Title: Validation specialist IV
Duration: 12 months
Location: Portsmouth, NH 03801
 
Summary: Analytical Validation specialist IV will lead validation activities including, but not limited to, software updates, new system introduction, and decommissioning of analytical systems. This person will work closely with other functional groups like Manufacturing, Operations Technology, Computer System Validation, Engineering, and Quality Assurance to support updates to help the site remain in compliance and contribute to quality, on-time delivery and right first time performance.
 
Job Description (Key Accountabilities)

• Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments. for the design, operation and troubleshooting of analytical equipment.
• Drive/own the validation plans and execution of analytical equipment changes and process improvements.
• Execution of  Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
• Own all forms of TW records including CC/CAPA/Deviations to support project completion.
• Generating User Requirements Specification Documentation, complete Electronic Records/Electronic Signatures, Data Integrity Risk Assessments and Audit Trail Risk Assessments.
• Review analytical equipment, manuals, and devise validation plans
• Procurement of Analytical Equipment which includes ensuring system meets specifications, quotes, budgets and installations.
• Works in partnership as an active member of their team and cross- functional working groups.
• Generously shares information and knowledge with others across teams and functions.
• Actively seeks out and shares different perspectives from a broad network and implements alternative approaches.
• Champions and role models the values of diversity and inclusion through everyday interactions in groups or 1:1s.
• Proactively seeks to understand internal/external customer and market needs.
• Develops insights that can be used to enhance customer satisfaction or other metrics.
• Identifies when company and customer interests may not align and seeks effective solutions to resolve or escalate.
• Manages internal and external customer relations professionally and effectively.
• Uses systematic approaches to ensure customer key metrics are tracked and analyzed for continuous improvement.
• Analytical Equipment Ownership.
• Identify Quality Issues, involve stakeholders, drive to completion/resolution.
• Participate on Risk Assessments.
• Review/Approve Commissioning Qualification Validation Documents.
• Perform other duties as assigned.

 
Qualifications

• Bachelor of Science degree required (Science-related discipline or relevant experience in the field).
• 5-10 years of Manufacturing, QC, Validation experience required.

 
Skills

• Advanced technical knowledge of Quality control and manufacturing operations.
• Working knowledge and experience with Quality Systems including deviations, change controls, CAPAs, OTNs, deviations; both the system (TrackWise) and the practical applications in operations.
• Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment.
• Demonstrated ability to manage medium to large sized projects within required timeframes.
• Demonstrated ability for effective Planning, Organizing and Controlling competency.
• Demonstrate sound decision making.
• Ability to work inter-departmentally and with customers.
• Demonstrates role model behaviors for GMP and Safety behaviors.
• Strong written and verbal communication skills.
• Ability to work in MS Project, Word, Excel, PowerPoint.  

 

About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
 
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
 
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer. 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $47.42/hr.