QA Validation Specialist

POSITION DESCRIPTION

Position Title: QA Validation Specialist Department: QA

Reports To: Director of Quality Assurance Work Location: Decatur, Illinois

Position Summary:

Provide expertise, guidance, and oversight for the Qualification/Validation compliance at the Decatur Site. Manage site compliance with current FDA regulatory requirements and expertise to work with all levels of management, staff, and internal departments as applicable. Through technical expertise and a commitment to continuous improvement of the qualification/validation compliance, the QA Validation specialist upholds our dedication to product quality and patient safety.

Essential Duties & Responsibilities:

Provide expertise in the review/approval of validation protocols and reports but not limited to steam sterilization, environmental monitoring, clean utilities, process equipment, temperature mappings, cleaning validation, process validation etc. Ensure the compliance of requalification schedule for facilities, equipment and processes based on a risk assessment, current industry "best practices," and regulatory requirements. Responsible for ensuring the compliance state of Validation Master Plan Schedules, including facility, equipment, and process requalification’s. Excellent working knowledge of cGMP requirements on validation methods and principals including ISPE, GAMP guidelines, and FDA, CFR Part 11 Electronic Records and Signatures requirements. Able to mentor and train staff, and other resources as needed. Able to guide the validation team for developing applicable validation documentation, including, but limited to URSs, FDSs, DOEs, FATs, IQs, OQs, PQs, and VQs from scratch/manuals, if not readily available. Able to handle multiple, complex projects and work independently.

Additional Responsibilities:

Other duties as assigned.

Education and Experience:

Bachelor's Degree from a four-year accredited college or university with Major in Pharmacy, Chemistry or Microbiology or equivalent work experience in the pharmaceutical industry for at least 8 years. Sterile injectable experience required.

Job Prerequisites:

Ability to meet attendance standards. All full-time employees are required to work a 40 hour week, most of which has to be during "regular" business hours. At times it may be necessary to work additional hours to get the required tasks accomplished to meet deadlines. Excellent communication, writing, and computer skills. Ability to operate and troubleshoot validation monitoring equipment. Ability to estimate and maintain project timelines. Fully knowledgeable with computerized systems and programs.

Physical Demands, Mental Requirements, and Work Environment:

While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use.

Mental Requirements

Ability to apply deductive reasoning and understand complicated issues; Ability to provide instructions and follow up work rules including company policies; Ability to ensure safety and security practices; Ability to accurately communicate ideas, facts, and technical information; and Maintain confidentiality of certain information.