Basic Function
To ensure that all products manufactured and/or packaged at Trillium are safe, pure, and effective, and that they comply with established quality standards and specifications according to current Good Manufacturing Practices guidelines.
Responsibilities
· Review manufacturing and packaging batch records to ensure accuracy and completeness for each lot of product processed.
· Review raw material and packaging component documentation and approve/reject receipts as required.
· Review in-process and finished product samples to determine product quality and lot acceptability.
· Ensure deficiencies and discrepancies are completed and reconciled as required prior to product release or disposition. Recommend appropriate corrective actions and follow-up as required.
· Approve/reject drug products as required. Complete required documentation and inventory status change.
· Complete internal or customer documentation requirements including Certificate of Analysis, Certificate of Conformance and other relevant information.
· Assist in internal (self-inspection) quality audits and other investigations as required to improve quality and compliance levels.
· Perform a systematic investigation of quality defect customer complaints for approved marketed products manufactured and/or packaged within the SOLABS EQMS system.
· Maintain internal complaint and rejection database.
· Review and approve calibration data using calibration software program.
· Monitor performance of temperature/humidity monitoring equipment.
· Lead, participate in, and/or review root cause investigations and proposed CAPA for deviation reports.
· Assess and document potential or known impact to quality of raw materials, packaging components, and/or finished goods product. Prepare risk assessments.
· Ensure Deviations are closed in timely manner.
· Inform customers of deviation reports as they are initiated and maintain communication with customer QA while investigations are in process.
· Administration of the Deviation Report tracking database and electronic and hard copy event reports.
· Back-up for review and approval of protocols related to AQLs, inspection, rework, reprocessing, repackaging, and other activities.
· Act as designate for Manufacturing Quality Assurance Supervisor.
· Draft monthly Quality Metrics related to right-the-first-time, finished product rejections, past due/aging Notices of Event, and AQL/rework/reprocessing/ repackaging/inspection activities.
· Other duties as assigned.
Qualifications
· Minimum 3 years’ experience in a Quality Assurance Role.
· Minimum Bachelor of Science Degree in a related science
· Demonstrated problem solving skills
· Demonstrated technical writing skills
Job Types: Full-time, Permanent
Salary: From $65,000.00 per year
Ability to commute/relocate:
Education:
Experience:
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