CSV Analyst

Job Title: CSV QA Analyst

Location: Concord, NC

Industry: Pharmaceutical

**NO C2C**

Job Description:

Theoris Services is assisting our client in their search for a CSV QA Analyst to add to their growing team located in Concord, NC. Our client is seeking an individual to assist in maintaining the life cycle management of computer systems, ensuring data integrity, and staying informed about both corporate and external standards related to CSV and Data Integrity (DI). A successful candidate will collaborate effectively with functional area data experts to anticipate and resolve key data management and integrity issues. They will drive solutions that not only impact the site but also align with corporate objectives. This role demands a deep understanding of GMP data flows, both electronic and paper, and the application of data management and integrity principles in operational processes. Additionally, the candidate will utilize Computer System Validation methodologies to ensure regulatory compliance, consistency, and sustainment.

Responsibilities:

Ensure the site computer system programs are established and compliant with corporate standards for IT systems and laboratory computer system lifecycle management programs.

Review and approve documents per CSV expectations within agreed service levels or clearly communicate when activities will be completed.

Create, revise and approve site compliance area documents, including specifications and procedures.

Collaborate with cross-functional partners, such as Manufacturing operations, TS/MS (Technical Sciences / Manufacturing Sciences), Engineering, Logistics, Automation, IT, and QC Labs, to streamline processes and sustain customer service

Investigate non-conformances associated with IT systems.

Approve GMP documents (examples: Minor non-conformances, procedures and change controls).

Create visual representations of data to communicate insights and the compliance status of the Site Quality Metrics to the Site Leadership Team.

Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Requirements:

Bachelor's degree in engineering, computer systems, or science-related field

At least 3 years of work experience in the pharmaceutical or medical device industry in QA, CSV, or DI roles.

Qualified candidates must be legally authorized to be employed in the United States. Client does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Preferred Requirements:

Proficiency with GMP computer systems validation including regulations governing them

Previous CSQA / CSV experience

Demonstrated strong oral and written communication and interpersonal interaction skills

Demonstrated strong technical writing skills

Ability to compile/analyze data and metrics in reports understandable by management and business partners.

Attention to detail, self-management, problem solving; mentoring.

Previous experience with Quality management systems (QMS) including TrackWise and Veeva.

Previous experience with ITSM/CMDB tools including ServiceNow.

Previous experience with Requirements and Testing tools including ALM.

Previous experience with device and parenteral product materials

Previous experience with deviation and change management systems including TrackWise/Veeva/ServiceNow

Other Information:

Ability to work 8-hour days – Monday through Friday is required on site; up to 4 days per month (e.g. 1 day per week) may be WFH applicable.

May require support outside of regular schedule (weekend days or off-hours) in support of continuous (24/7) manufacturing operations.

Best-In-Class-Benefits

We are in the people business; treating people right is our ONLY priority. Theoris Services consultants are full-time employees with full benefits, including:

Robust Health Insurance

401(k) plan

PTO accrual

Paid holidays

Excellent cash-based referral program