The role is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. He/She is expected to fully participate in both departmental projects and any quality working teams which may be applicable. He/She initiates new documents for procedures which are simple in nature and may also make minor revisions to existing documents. The incumbent can troubleshoot simple existing procedures. He/She may demonstrate procedures as a part of a training session and may schedule department or process activities which could involve coworkers.
Job Function and Description
â¢ Prepare media and buffer solutions.
â¢ Operate Clean-in-Place (CIP) and Steam-in-Place systems.
â¢ Assemble and operate filtration systems.
â¢ Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers, etc.).
â¢ Monitor and record critical process parameters.
â¢ Complete all relevant paperwork following GDP/GMP guidelines.
â¢ Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion.
â¢ Perform sampling using aseptic techniques.
â¢ Participate on Continuous Improvement Teams.
â¢ Receive and distribute supplies into production areas as necessary.
â¢ Train and mentor other team members.
â¢ Revise and review pertinent documentation as appropriate.
â¢ Assist in troubleshooting process problems and responding to alarms.
â¢ May perform other duties as assigned
Typically requires high school diploma or GED plus 1+ years of related experience or associatesâ degree or higher with no prior experience required.
Knowledge of cGMP manufacturing. â¢ Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems. â¢ Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement. â¢ Must be able to read and follow detailed written instructions and have good verbal/written communication skills. â¢ Knowledge of basic chemical and biological safety procedures. â¢ Good computer skills, knowledge of Microsoft Word and Excel. â¢ Good interpersonal skills and be able to work effectively and efficiently in a team environment.
â¢ Must be able to carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment). â¢ Must be able to stand for extended periods of time over an entire 8 or 12-hour shift. â¢ Must be able to climb ladders and stairs while wearing special gowning. â¢ May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks. â¢ Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. â¢ No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment. â¢ Will work in a cold, wet environment. â¢ Must be able to work multiple shifts, including weekends. Must be able to work overtime Job Description 3 as required. â¢ May be required to work in a confined area. â¢ Some Clean Room and cool/hot storage conditions. â¢ May require immunization before performing work within the manufacturing area
USA - GA - Social Circle - Hwy 278
Internal Number: R0027673
About Biolife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.