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Form of workJob Title: Manufacturing Associate
Location: Harmans, MD
Duration: 6 Months on W2 (Temp-to-Hire)
Shift: 7AM - 7PM : Rotating Schedule Every 2 Weeks 2 ON, 2 OFF, 3 ON, 2 OFF, 2 ON AND 3 OFF.
POSITION SUMMARY:
The Manufacturing Associate : Perform and Documents cGMP activities to support upstream or downstream production areas and operations. This involves operation of process equipment, execution of validation protocols, completion of cGMP documents, creating/ revising cGMP documents and other assignments as directed.
Shift work and/or weekend work may be required at times.
KEY RESPONSIBILITIES
POSITION REQUIREMENTS:
Location: Harmans, MD
Duration: 6 Months on W2 (Temp-to-Hire)
Shift: 7AM - 7PM : Rotating Schedule Every 2 Weeks 2 ON, 2 OFF, 3 ON, 2 OFF, 2 ON AND 3 OFF.
POSITION SUMMARY:
The Manufacturing Associate : Perform and Documents cGMP activities to support upstream or downstream production areas and operations. This involves operation of process equipment, execution of validation protocols, completion of cGMP documents, creating/ revising cGMP documents and other assignments as directed.
Shift work and/or weekend work may be required at times.
KEY RESPONSIBILITIES
- Performs Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record.
- Documents/Records cGMP data and information for processing steps and/or equipment activities, following standard operating procedures. Key documentation includes batch records and equipment logbooks.
- Understands basic cGMP requirements and follows those requirements, including requirements for good documentation practices.
- Completes /reviews validation protocols, deviation reports, change controls in accordance with cGMP's
- Performs the weighing, dispensing of raw materials for media and buffers
- Performs the preparation of small and large volume media and buffer solutions, filtration, and transfer of product.
- Operates bench top equipment including pH, conductivity, osmo meters, pumps, tubing welders, filter integrity testers etc.
- Dispensing, labeling, transfer/staging of raw materials and parts
- Assembly/disassembly, cleaning and sterilization of components, parts, and equipment
- Maintaining equipment, area, and cleaning logbooks
- Cleaning sanitizing production rooms and equipment
- Stocking production and cleaning supplies
- May author/ review/improve SOP's, batch records, protocols, and technical reports
- Actively participates in training activities, managing their individual training plan.
- Proficient and knowledgeable in the operation and basic troubleshooting of at least one manufacturing area.
- Other duties as assigned
POSITION REQUIREMENTS:
- High School Diploma with a minimum of 2-4 years GMP Manufacturing experience OR
- Certificate and/or associate degree in a scientific, engineering or biotechnology discipline with a minimum of 0-2 years related experience; coursework with biotechnology focus highly desirable,OR
- Bachelor's Degree (BS/BA) from an accredited college or university with an emphasis in a scientific or engineering discipline and a minimum of 0-1 years relevant experience.
- Basic knowledge of current Good Manufacturing Practices (cGMP's). Working knowledge of all relevant safety procedures within the company. General understanding of most areas in Manufacturing and supporting functional groups.
- Familiar with or experience with cGMP Biotech or Pharmaceutical operations:
- Must be team-oriented (proactively builds healthy working relationships between peers, their department, and other groups).
- Able to fluently communicate in English. Exhibits excellent written and oral communication skills.
- Possesses a basic knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.
