Manufacturing Associate Job at ALLTECH CONSULTING SVC INC in Glen Burnie

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 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 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: • High School Diploma with a minimum of 2-4 years GMP Manufacturing experience, OR • Associate’s Degree in a scientific, engineering or biotechnology discipline with a minimum of 1-2 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 ascientific or engineering disciplineand 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. #J-18808-Ljbffr