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.
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:
• Bachelor’s Degree (BS/BA) from an accredited college or university with an emphasis in a scientific or engineering discipline and some relevant work 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.
PHYSICAL DEMANDS:
• Extended amount of time walking, standing, bending, reaching, pushing, and pulling.
...LETTS CONSULT is conducting a search for a dynamic and hands-on General Manager to lead an outdoor hospitality property in the Williamsburg VA area, where nature meets exceptional guest service. This role is ideal for someone who thrives in a scenic, fast-paced environment...
...Our client, a fun-loving and fast growing childrenswear brand is seeking a highly creative, skilled and strategic Designer to join their growing team in NYC. Responsibilities: Support the Design Director with the design process from concept to execution for seasonal...
******This position is on W2***** Job Title: Copywriter Location: Culver City, CA (hybrid) Duration: 12-month contract on W2 Job Description: As a copywriter in Client Video Services group, you will play a pivotal role in shaping how consumers around the...
P osition Overview Responsible for organizing, handling, and following general maintenance and electrical needs for machinery and equipment, as well as the facility. Key Accountabilities Electrical Work 50% Install and maintain electrical systems such as ...
...Akkodis is seeking a Computer Field Technician (Laptops & Printers Repair) for a 24 Months contract position with a client located in Irving, TX. Ideally looking for applicants with a strong working knowledge of imaging computers, desktops, laptops and printers comes...