The role is responsible for executingÂ allÂ processes inÂ production whileÂ strictly adhering to cGMP, environmental health and safety guidelines andÂ anyÂ otherÂ relatedÂ regulationsÂ whichÂ could apply. He/She is expected to fully participate in both departmental projects and any quality working teams which may be applicable.Â He/SheÂ initiatesÂ newÂ documentsÂ for proceduresÂ which are simpleÂ inÂ nature and may alsoÂ make minor revisions to existing documents.Â The incumbentÂ Â Â can troubleshoot simple existing procedures. He/She may demonstrate procedures as a part of a training session and may schedule department orÂ processÂ activitiesÂ whichÂ couldÂ involveÂ coworkers.
Job Function and Description
Prepare media and buffer solutions.
Operate Clean-in-Place (CIP) and Steam-in-Place systems. Assemble and operate filtration systems.
Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers, etc.).
Monitor and record critical process parameters.
Complete all relevant paperwork following GDP/GMP guidelines.
Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion.
Perform sampling using aseptic techniques. Participate on Continuous Improvement Teams.
Receive and distribute supplies into production areas as necessary. Train and mentor other team members.
Revise and review pertinent documentation as appropriate.
Assist in troubleshooting process problems and responding to alarms. May perform other duties as assigned.
Education and Experience Requirements
Typically requires high school diploma or GED plus 1+ years of related experience or Â or higher with no prior experience required.
Key Skills, Abilities, and Competencies
Describe critical skill and abilities needed to successfully perform the job, which should be representative of the knowledge, skills, and abilities required. Reasonable accommodations may be
made to enable individuals with disabilities to perform the essential functions.
Knowledge of cGMP manufacturing.
Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems.
Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
Knowledge of basic chemical and biological safety procedures. Good computer skills, knowledge of Microsoft Word and Excel.
Good interpersonal skills and be able to work effectively and efficiently in a team environment.
Other Job Requirements
List any other job requirements, including travel, physical abilities required, etc.
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).
Must be able to stand for extended periods of time over an entire 8 or 12-hour shift. Must be able to climb ladders and stairs while wearing special gowning.
May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks.
Must be able to work in controlled environmentsÂ requiring special gowning. Will beÂ required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the
Will work in a cold, wet environment.
Must be able to work multiple shifts, including weekends. Must be able to work overtimeÂ as required.
May be required to work in a confined area.
Some Clean Room and cool/hot storage conditions.
May require immunization before performing work within the manufacturing area.
USA - GA - Social Circle - Hwy 278
Internal Number: R0029140
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.