Computer System Validation Specialist

Quality Chemical Laboratories   Wilmington, NC   Full-time     Information Services / Technology (IT)
Posted on September 15, 2022

Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of System Validation and Data Integrity Specialist.

Responsibilities include: Plan and write protocols for computer system validation projects per 21 CFR Part 1, Review validated systems to assess need for further enhancements, validation, or system upgrades/fixes, Work with company management to implement changes and upgrades to computer systems, Work with vendors on purchasing and planning for software upgrades, Review vendor protocols/design specifications,  Perform risk assessments for existing and new computer systems, Monitor validation activities and communicates problem areas to quality assurance management, Participate in client and regulatory audits, Collaborate with other representatives from the quality department, Coordinate end user training.  Candidates with experience in a pharmaceutical setting, as well as experience with GAMP5 and Computer Validation are preferred. Must be results driven, a self-starter, and possess strong interpersonal and communication skills in addition to strong verbal and technical writing skills.

QCL offers competitive salaries commensurate with experience and an excellent benefits package as well as great potential for career advancement and leadership in a rapidly growing company.