Please note that this is a 6 months contract position.
Manager would like this position to be on site at the Boulder site.
The QA/Validation Engineer is responsible for Quality Assurance oversight of the validation program and activities at Nucleic Acid Solutions Division (NASD). Provide Quality oversight of commissioning, qualification, cleaning, and process validation activities as needed.
Responsible for reviewing validation documentation including but not limited to validation plans, protocols, final reports to ensure compliance with procedural and cGMP requirements. This position, at the Advanced and Expert level, has authority to act as a delegate for the Product Quality Manager and at all levels for other Quality Assurance (QA) Validation Engineers.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Quality oversight of validation activities.
Consults with and provides guidance, training, and/or direction from a quality perspective to other departments.
Revises, reviews, and/or approves documents including, but not limited to validation policies, SOPs, plans, risk assessments, protocols and reports.
Performs Quality Assurance review and approval for validation documentation, such as user requirement specification, commissioning documentation, protocols & reports, Quality Incident Reports (QIRs), and product/validation impact assessments relating to material, equipment, cleaning, computer or process changes.
Leads or participates in risk assessments associated with validation activities.
Collaborates with cross functional teams (Information Technology, Engineering, Quality Control, Analytical Services, Manufacturing, and Process Development) to prioritize validation activities and ensure overall project timelines and site objectives are met.
Supports other departments to evaluate and resolve validation issues and to address validation related activities.
Generates, reviews and/or approves Nonconformance Investigations, Corrective Action / Preventive Actions (CAPAs) and Change Control records related to validation activities.
Supports post-approval changes from a validation perspective to ensure the manufacturing process remains in a state of control.
KNOWLEDGE, SKILLS, AND ABILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Knowledge of GMP guidelines and international regulations pertaining to the production of APIs including, but not limited to, ICH, 21 CFR 210 and 211, 21 CFR Part 11, EudraLex and GAMP5.
Knowledge and experience in execution and/or Quality oversight of commissioning, qualification/validation, and remediation activities.
Experience supporting nonconformance investigations, CAPA, and change control programs.
Strong technical writing and communication skills (written and verbal).
Excellent teamwork and problem-solving skills. Ability to collaborate with cross functional teams to assess changes and nonconformances for impact to validation.
Excellent time, priority and project management skills. Must be able to use individual discretion in completing work assignments while assisting the group in establishing priorities, setting standards and working collaboratively to accomplish deadlines and objectives.
Ability to read, analyze, and interpret industry related periodicals, SOPs, and government regulations. Ability to write reports, business correspondence, and procedures.
Must have skill in using computers and software applications (MS Word, MS Excel, and Adobe Acrobat). Knowledge of statistical methods for use in data analysis a plus.
Bachelor's or Master's degree or equivalent engineering or related life sciences field; and a minimum of 4 years (Advanced) / 8 years (Expert) validation related experience; or equivalent combination of education and experience.
Requires in-depth knowledge and experience in job and ability to work independently.
Applicants must provide their phone number. Reference job number A823.