What are the responsibilities and job description for the Manufacturing Associate position at HireTalent?
Job Title : Manufacturing Associate
Job Location : Harmans, MD
Job Duration : Months
Shift Timings : : AM - : PM ( Rotation)
Job Description :
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 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 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
Education & Experience :
PHYSICAL DEMANDS :
