To collect all batch records for final review/approval. Obtain appropriate laboratory data for each batch. Maintain all batch records and Master files appropriately. Generate all Certificates of Analysis. Perform other related duties as needed.
Duties & Responsibilities:
Collect all manufacturing, packaging, laboratory and receiving documents to complete final batch record.
Store all documents appropriately in a locked, secure location
Create certificates of analysis for each production batch based on results collected from appropriate lab staff.
Provide back up for the Administration Assistant by issuing formulas, creating labels for production and preparing samples to be sent to outside laboratories for testing when necessary.
Organizes and schedules all calibration of manufacturing equipment and laboratory equipment.
Schedules Pest Control and maintains all Pest Control records.
Maintains all logs for change control, deviations, rework, and rejections.
Maintains all employee training records
Sends raw material and finished product samples out for outside testing.
Orders office supplies
Tending to visitors. Ensuring they are in compliance with MDC's Visitor Policy, signing in and gowning up before entering production areas etc.
In the event that the appropriate personnel is not available to do so, responsible for distributing mail and interoffice envelopes.
Employee Training-maintain and file all employee training files. Create assessment with the guidance of the appropriate department. Issue assessments. This may involve direction from President, Director of Quality, or Director of Manufacturing.
Assist Quality Assurance in maintaining SOP distribution files and logbooks. This includes a review of the SOP books that are throughout the manufacturing departments. Also, must maintain obsolete SOPs and fill out appropriate forms. May be asked to assist in typing out changes to SOPs.
Assist Quality Assurance in maintaining all Quality logs/spreadsheets. Responsible for filing old quality logs in the appropriate place. This includes all cleaning logs.
Processes change controls. This includes filling out the proper documentation, logging, and filing both the changes and the obsolete records.
Responsible for calculating the theoretical lead amount on formulas as needed.
Responsible for collecting and logging temperature and humidity charts.
Responsible for filing master batch records and batch records. This responsibility shall be shared with the Documentation specialist.
Typically reports to President or Director of Quality, this may vary as the circumstances arise.
Education, Knowledge and Skills:
Basic understanding of cGMP regulations
Read, write and speak English
Intermediate mathematical knowledge
Simple data entry skills
Credentials & Experience:
Minimum 2 years of experience in quality or related field
Understanding of tablet/capsule manufacturing/packaging operation