Summary:
The Quality Analyst is responsible for performing Quality Assurance (QA) oversight of GMP compounding activities at SCA Pharmaceuticals. The Quality Analyst assists system owners in performance of non-conformance investigations, executes CAPA’s as they pertain to the QA department and supports validation and technical change control activities. This position requires advanced understanding of site processes in order to write technical documents including engineering studies and standard operating procedures.
The position is a non-management position. The individual occupying it is expected to be capable of working with minimal supervision. The Quality Assurance Analyst is expected to communicate well with fellow Quality Assurance employees as well as Operations and Pharmacy departments.
Essential Functions:
- Conduct evaluations and process audits of production personnel to ensure procedures are being followed in accordance with GMP compliance.
- Provide guidance, as requested, to production employees with the intent to foster understanding and compliance with SOPs and process improvements.
- Provide input and decision making for quality on the shop floor with regard to manufacturing deviations. Provide corrective actions as necessary.
- Author technical documents for the site including standard operating procedures (SOPs), investigations, corrective and preventative action plans.
- Maintain training records and act as a site coordinator for the company training management system.
- Review and evaluate production batch records and QC data for release as required.
- Perform data analysis, identify corrective/preventative actions, and evaluate site Technical Change Control documents (TCCs), process deviations and investigation reports.
- Perform inspection of drug product rejects/complaint investigation samples as part of QA investigations.
- Assist in the coaching and training of production employees for Quality Assurance related annual required cGMP and Aseptic trainings.
- Performs other duties as assigned.
Successful Candidates Will Have:
- • Strong written and verbal communication
- • Ability to work with minimal supervision
- • Experience working in MS Word and Excel
Supervisory Responsibilities
- This position will not have any supervisory responsibilities however will lead/direct others in all matters of quality assurance.
Work Environment
- This position often works in all areas of our production/manufacturing areas while being involved quality matters and inspections. Proper protective equipment will be worn at all times and on occasion being completely “garbed up”.
Physical Demands
- Sitting, standing and walking often throughout all areas
- Reaching with hands/arms
- Bending and reaching in hard to access areas
Qualifications:
- Minimum: Bachelor’s degree in a scientific discipline with 1+ years’ experience in a cGMP/FDA regulated environment
- Preferred: Bachelor’s degree in a scientific discipline with 2+ years’ Quality Assurance experience in a cGMP/FDA regulated environment
SCA Pharmaceuticals is an equal opportunity employer (Minorities/Females/Disabled/Veterans). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.