What are the responsibilities and job description for the Manufacturing Associate position at Planet Pharma?
The Manufacturing Associate I performs 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.
- Lifting to 40 lbs., unassisted may be required at times.
- Frequent standing and walking is required, as this role requires presence on the manufacturing floor.
- Shift work and weekend work is required.
Key Responsibilities include but are not limited to:
- 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 cGMPs
- 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 SOPs, 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
Education & Experience:
- High School Diploma with a minimum of 2-4 years GMP Manufacturing experience, OR
- Associates Degree in a scientific, engineering or biotechnology discipline with a minimum of 1-2 years related experience; coursework with biotechnology focus highly desirable, OR
- Bachelors Degree (BS/BA) from an accredited college or university with an emphasis in ascientific or engineering disciplineand some relevant work experience
- Basic knowledge of current Good Manufacturing Practices (cGMPs). 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.
PHYSICAL DEMANDS:
- Extended amount of time walking, standing, bending, reaching, pushing, and pulling.
Salary : $53,000 - $63,000
