Compounder (Brampton, CA) na None

Job purpose

Responsible for the cleaning, setting up and operation of manufacturing equipment as part of the process of compounding pharmaceutical creams, ointments, gels and liquids. 

Duties and responsibilities

•    Complete G.M.P. documents, such as the Batch Record, cleaning & sanitizing logs, housekeeping logs and other documents / log records pertaining to manufacturing
•    Follow safety rules/regulations and report any workplace injuries or accidents. Assist when required to improve equipment safety related procedures. Wash and sanitize compounding rooms and vessels
•    Compounding batches as per SOP’s and Master Formulas. Report discrepancies and deviations in a timely manner to compounding lead hand or supervisor
•    Dispense raw materials when required
•    Perform accurate inventory transactions using SAP
•    Maintain a clean and organized working environment. Familiar with 5S processes and Lean Manufacturing Concepts
•    Participate and assist with continuous improvement projects and processes
•    Work safely and accurately with a focus on completing tasks and documentation right first time
•    Complete all GMP Documentation correctly and in a timely manner
•    Complete all training assignments and maintain personal training records
•    Participate in and/or lead Non-Conformance Investigations 
•    Complete Corrective and Preventive Actions (CAPA’s)
•    Initiate, and follow through with actions required to close Change Controls
•    Participate in Internal, Customer and Regulatory Audits.
•    Assist with the training of new compounders
•    Perform start-up and shutdown procedures for all vessels
•    Minor repairs to the facility and equipment where applicable
•    Perform verification checks for equipment (scales, mixers, pH meters) used in manufacturing as per predefined time periods
•    May be required to assist Validation or Pharmaceutical Technology staff with new formulations and scale ups
•    May be required to assist with investigations where necessary
•    Notify compounding lead hand and mechanic in a timely manner if equipment parts and compounding consumables are low in quantity
•    Other duties as assigned.

Additional responsibility (Only applicable to customer facing roles)

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

•    University degree with 1-2 years of technical training experience
•    Post-Secondary education in scientific discipline is preferred or a minimum of 5 years’ experience in a pharmaceutical environment
•    Must possess the ability to function effectively in a team environment
•    Must be able to actively listen and receive coaching and applicable training
•    FL licence preferred
•    Excellent math skills 
•    Proficient in MS Word, Excel, PowerPoint and Lotus Notes. Must be comfortable with use of tablets and trainable on associated programs (MES, SAP)
•    Excellent verbal communication skills for interacting with personnel on a daily basis
•    Previous experience in a pharmaceutical manufacturing environment
•    Issues that may arise that have a GMP impact are evaluated at the time of occurrence in conjunction with the supervisor and QA.

Working conditions

•    Overtime will be required to address priority items. This may be additional time during the work week and / or on weekends with last minute notice
•    Shift work required which may include weekends
•    Use of G.M.P garments and Safety Equipment (PPE) as required

Physical requirements

•    Physically fit, able to lift at least 25 kgs
•    Stand for long periods of time
•    Bending and “squatting” throughout the work day

Direct reports

NA