Proclinical is currently recruiting for a Lab Associate with a pharmaceutical company located in Brooklyn Park, MN. This position performs and documents daily manufacturing operations according to SOP's in a cGMP environment. They will operate biologics production equipment (bioreactors, filtration units, chromatography systems and fixed/portable vessels), execute validation protocols, and create or revise cGMP documents
- With general supervision or guidance will assemble and/or operate biologics production equipment, such as bioreactors, filtration units, chromatography systems and fixed/portable vessels
- Perform basic trouble shooting
- Performs/assists with processing steps and/or manufacturing support activities by monitoring process parameters in batch record and control systems
- Documents cGMP data and information for processing steps and/or equipment activities while following standard operating procedures. Key documentation includes batch records, work orders, and equipment logbooks.
- Executes batch records and validation protocols under supervision/direction of others
- Author and review equipment use logs
- Performs inventory transactions in SAP
- Performs data entry into LIMS
- Accountable for completing assigned trainings within required timeline and actively participate in training activities.
- Stock production and cleaning supplies
- Perform cleaning/sanitizing production rooms and equipment
- Other duties as assigned
Skills and Requirements:
- Bachelor's degree in Science or Engineering
- They need to be able to work 12-hour shifts (5:45 AM to 6:15 PM OR 5:45 PM to 6:15 AM)
- They need to be able to work weekends (Schedule which alternates 3 days and 4 days each week)
- Science graduates from local universities, or people with some GMP experience and attention to detail
- Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) preferred
- Familiar or experience with cGMP within Biotech or Pharmaceutical operations preferred
- Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management a plus
- Prior experience with lab equipment a plus
- Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding.
- Must have excellent written and oral communication skills
- Must be team and detail-oriented and able to work in a fast-paced environment.
- Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Web Based Training (WBT)
- Must be able to read and understand English
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Nikki Ranieri at 215-531-5288 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.