Manufacturing Specialist - 2nd Shift

Duties And Responsibilities

• Performs cell manufacturing related activities while wearing clean room attire in an aseptic cGMP manner.
• SME on unit operations.
• Documents production operations in corresponding batch records and logbooks per established procedures ensuring accuracy and timely completion.
• Identifies real-time manufacturing issues (deviations and atypical results) and communicates them to Manufacturing Management and the Quality team in a timely manner.
• Authors or edits SOPs, batch records, training records, logbooks, validation plans and technical reports as assigned.
• Handles human blood and human blood-based product intermediates;
• Helps with warehouse management, critical reagents and material inventory reports.
• Work on project teams (continuous improvement initiatives)
• Inputting and uploading of manufacturing data in real time to existing database.
• Review of Batch Records and logbooks / comment resolution.
• Train new or junior employees on equipment and unit operations.

Qualifications

• Bachelor’s degree in a cell biology, bioengineering or medical technology related field, or equivalent experience is required.
• Minimum 1 year working with Advanced Cell Therapies within a cGMP environment.
• Ability to work flexible hours with some night and weekend availability is required.
• This is a start-up situation so schedules and shifts will change over time.
• Demonstrated strong understanding of GMP/GDP (21 CFR Part 210/211 & 21CFR Part 11).
• Ability to stand for multiple hours and lift 20 pounds.
• Experience working in an aseptic cleanroom with full aseptic gowning.
• Excellent verbal and written communication skills are required.
• Computer literacy is required including Microsoft Outlook, Word, Excel and Power Point.

Competencies

• Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
• Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
• Computer Skills – Skilled with computers; Takes advantage of new technology; Learns new tools quickly; Uses technology to enhance job performance.
• Conflict Management – Good listener; Committed to finding solution to problems; Works well with people.
• Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
• Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
• Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.