What are the responsibilities and job description for the MANUFACTURING GMP SUPPORT position at Apollo Professional Solutions?
Job Description
Description :
On site only at South San Francisco location. Night shift hours are 7pm-8am 3 days one week 4 days the next week. N1 team is Sun-Tues N2 is Wed-Fri both teams alternating Saturdays
- Responsible for producing innovative bio therapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness.
- Perform cleaning and disinfection of ceilings, walls, floors, equipment and surfaces in a cleanroom environment.
- Comply with annual Aseptic medical evaluations
- Operate and support manufacturing equipment such as the autoclaves to prepare for GMP processing.
- Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).
- Responsible for being proficient in one functional area.
- Understands and applies biological, chemical and mechanical principles and techniques.
- Job Responsibilities Perform sanitization and cleaning per governing SOPs in Grade A / B GMP spaces.
- Clean, assemble, and sterilize equipment using washers and autoclaves.
- Perform facility FIT walkthroughs and create work orders to fix any issues observed.
- Monitor and perform audits of tasks such as cleaning and pest control operations within classified environment Responsible to participate in cycle counting and inventory of sanitization supplies and gowning articles in order to maintain inventory levels for timely reordering.
- Operate systems that clean and sterilize tanks and filtration systems.
- Prepare solutions for the production process.
- Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
- Troubleshoot equipment and process problems.
- Comply with safety requirements, cGMP, SOP and manufacturing documentation.
- Use of automation to perform production operations.
- Provide support to Manufacturing to meet production demands.
- Operate automated systems for equipment operation.
- Assemble and prepare equipment for production.
- Exhibit detail oriented documentation skills Communicate effectively and ability to work in a team environment.
- Exhibit professional interpersonal skills.
- Work with coworkers and supervisor to effectively troubleshoot minor equipment and process issues.
- Follows established safety and environmental guidelines and procedures for all work performed.
- Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.
- Fosters a positive safety culture in which no one gets hurt.
- A good working knowledge of biopharmaceutical technology and processes.
- Trained and skilled in all operational procedures of at least one manufacturing department.
- Demonstrated ability to independently document and record information related to the process.
- Occasionally makes routine decisions based on experience.
- Identifies and suggests solutions to common basic problems.
- Recognizes non-routine problems, investigates and suggests potential solutions.
- Judgment is required in resolving problems and making routine recommendations.
- Ability to recognize deviation from accepted practices is required.
Job Requirements
Education and Experience
High School and 1-3 year related experience working in a GMP work environment
Biotech certificate from approved program
Knowledge, Skills, and Abilities Strong oral and written communication skills.
Work Environment / Physical Demands / Safety Considerations
Schedule could include a non-rotating 3 or 4-day (12 hour shift including one weekend day), evening or night hours, or full off-shift hours.
EEO Statement Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.
