- Downstream Production - 1st Shift
GENERAL SUMMARY (FUNDAMENTAL PURPOSE OF THE POSITION):
- Responsible for pharmaceutical manufacturing in compliance with current Good Manufacturing Practice (cGMP)
ESSENTIAL FUNCTIONS (PRIMARY RESPONSIBILITIES)
- Ensures consistent completion of all the planned manufacturing activities assigned to him/herself.
- Minimize waste of the resources (worktime, materials, and components).
- Organize workplace to maximize the throughput and minimize risks of errors.
- Follow well defined procedures closely, with attention to detail.
- Practice strong aseptic technique.
- Document activities accurately and clearly as per GDP.
- Operate manufacturing equipment according to well defined procedures.
- Daily monitoring of the process.
- Minor maintenance of manufacturing equipment as trained.
- Preparation of media, supplements, and/or buffers, where applicable.
- Revise/draft standard operating procedures (SOPs) as necessary.
- Report and document deviations, when encountered.
- Troubleshoot and recommend corrective/preventive actions (CAPAs), where applicable.
- Ensures that organizational KPIs are consistently achieved.
- Draft deviations, CAPAs, and/or change controls, where requested.
- Review completed manufacturing records for accuracy.
- Ensure compliance in operations.
- Proactively communicate and escalate to management any outstanding issues, or concerns of a compliance, quality, safety, or any other critical matter.
CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES):
- Effective communication (oral and written), organizational, and interpersonal skills.
- Ability to work well within a team environment.
- Ability to document clearly and accurately as per GDP.
- Ability to follow SOPs as written.
- Possess strong aseptic technique.
- Be proficient with MS Office.
- Have an aptitude for troubleshooting.
- Be proactive in identifying, communicating and escalating issues.
- Have ability to closely review documentation as per GDP.
EDUCATION/ EXPERIENCE (MUST INCLUDE MINIMUM REQUIREMENTS NECESSARY TO PERFORM ESSENTIAL JOB FUNCTIONS; ADDITIONAL PREFERENCES OPTIONAL)
- High School Diploma required. Associates degree/Bachelors degree in the sciences or engineering discipline with 0 to 1 years experience in a cGMP manufacturing industry or 2-4 years of proven work experience.
Zolon TechZolon Tech, Inc. (ZTI) is a fast-growing, 8(a) certified business providing Information Technology solutions and services to Federal and commercial clients. ZTI is CMMI Level 3, ITIL, and ISO 20000 certified and is a leader in the IT industry. Headquartered in Herndon- VA.