Address
Form of workQuality Assurance Associate (Early Career)
Permanent Role; Direct Hire
Lexington, KY Market
Pharmaceutical Manufacturing
SHIFT: 2nd Shift 3pm - 11:30 pm
Summary:
Responsible for providing quality involvement and engagement during all stages of pharmaceutical development, manufacturing and testing. Participates during the release of raw materials, intermediates and final products. Assists with internal and external audits of facilities and products, observes critical operations and procedures as they occur, audits documentation, records activities and keeps supervisors informed on quality issues.
Essential Duties:
Qualifications:
Permanent Role; Direct Hire
Lexington, KY Market
Pharmaceutical Manufacturing
SHIFT: 2nd Shift 3pm - 11:30 pm
Summary:
Responsible for providing quality involvement and engagement during all stages of pharmaceutical development, manufacturing and testing. Participates during the release of raw materials, intermediates and final products. Assists with internal and external audits of facilities and products, observes critical operations and procedures as they occur, audits documentation, records activities and keeps supervisors informed on quality issues.
Essential Duties:
- Supports the development and maintenance of Quality Systems as appropriate.
- Supports continuous improvement objectives to assure compliance with DEA and FDA regulations.
- Advises senior management on findings and recommendations related to internal and external auditing.
- Participates within the CAPA and Change Control Systems.
- Engages and maintains metrics and trending reports for Compliance-related activities.
- Performs activities associated with various one-time or on-going projects (from participation level to associate project management).
- Collaborates with departments and external suppliers regarding quality concerns.
- Participates in Compliance Assessments of departments as necessary (GXP, Part 11, etc.).
- Supports regulatory inspections and customer audits.
- Assists Manager with daily and project activities as needed.
- Other duties as assigned.
Qualifications:
- Bachelor degree in a scientific discipline
- At least 2 years Pharmaceutical/Medical Device cGMP quality experience
- Knowledge of HPLC principles and ability to review data for accuracy and completeness
- Ability to assess problems, to identify solutions, to plan and implement necessary changes
- Experience in quality systems auditing (internal and/or external) preferred
- Experience in manufacturing aseptically filled, sterile products preferred
- Advanced knowledge of cGMP regulations and validation principles
- Ability to work well in a team oriented environment
- Well-developed communication and technical writing skills
- Qualified to work with controlled substances
