Tittle-Quality Analyst IDuration- 04+ Contract Location- Opelika, AL 36801
Essential Duties and Responsibilities:
- Conducts reviews of documentation and reports for conformance to procedures, protocols and regulatory requirements.
- This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work.
- The incumbent will perform other duties assigned.
- Responsible for reviewing pertinent documents, records and reports such a Manufacturing Formulation Records (MFRs), Manufacturing batch Records (MBRs), etc. against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.
- Identify areas of non-conformance and inform management via the drafting of Non-Conformance Reports (NCRs) as needed to be disposed (unilaterally accepted or rejected) by others.
- NCRs at this level are minor and involve no patient risk. Administer and maintain relevant databases, preparing and issuing reports as defined by the area. Assist in external and internal audits by maintaining audit records, extracting data from databases and creating reports, collecting relevant data, etc.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.List knowledge, skills, and/or abilities required.
Education and/or Experience:
- Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- Strong interpersonal skills and great attention to detail are necessary.
- Must be a strong team player with good problem solving, and good verbal and written communication skills.
- Must be able to handle multiple projects concurrently, have computer experience
- Have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
- Include the education and experience that is necessary to perform the job satisfactorily.
- Bachelor’s degree in the life sciences and experience with a medical device/pharma or other similarly regulated industry preferred.