QC CSV Associate

Purpose and Scope

The QC Computer Systems Validation Associate is accountable for assisting with laboratory software validation on instrumentation including impact assessments, change controls and user requirements specifications. This includes upgrades and revalidation current software packages.

Essential Duties & Responsibilities

• Assist with the validation and maintenance of cGMP critical laboratory instruments and associated software and computers.
• Support IT projects and integration of lab systems into other company software systems.
• Support creation of new tools as part of process improvement initiatives.
• Assist in drafting documents in support of change controls related to the validation of software systems.
• Collaborate with IT related to QCC-associated IT projects.
• Support change controls in relation to laboratory computer systems including chromatographic data storage database, and sample tracking/reporting database.
• Support implementation of corrections required as part of audit findings.
• Support installation of new lab software systems and participate on project teams.
• Attend training sessions on GMP, statistics, and software as needed.
• Assist laboratory personnel and members of quality management with issues or troubleshooting related to computers, software and related databases.
• Generate ad-hoc reports of historical results of testing performed in the QC lab for laboratory management as well as other departments.
• Assist with writing, maintaining and editing standard operating procedures as needed.
• Maintain an atmosphere of teamwork, cordiality and respect towards co-workers.
• Perform other related duties as assigned.

Knowledge, Skills & Abilities

• Knowledge of software administration, user account creation and maintenance and computer system validation.
• Knowledge of computer usage for sample tracking, laboratory equipment, raw data handling and storage.
• Knowledge in the validation of new software systems.
• Proficient in cGMP guidelines.
• Knowledge of laboratory database design and maintenance.
• Experience in computer use/troubleshooting.
• Effective written and oral communication skills.
• Ability to work independently and with a team.

Core Values

• The QC Computer Systems Validation Associate is expected to operate within the framework of Tolmar’s Core Values:
• Consistently operate with the highest standards of ethics and compliance.
• Take ownership of your actions, success and setbacks.
• Respect each other and understand that honest collaboration is at the heart of our company success.
• Go the extra mile to make things happen.
• Be committed to all we do and the patients we serve.
• Embrace change with enthusiasm.
• Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

Education & Experience

• Bachelor’s degree required, preferably in Computer Science.
• One or more years of experience in an analytical laboratory.
• Experience in Laboratory Computer Systems gained through formal academic studies or work experience.

Compensation and Benefits

• Annual pay $60,000 - $62,000
• Benefits information: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Working Conditions

• Office and laboratory settings. Will be exposed to solvents, biohazardous materials and pharmaceuticals.

Education

Required
• Bachelors or better in Computer Science or related field

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)