HIRING Production Specialist! Medix Life Sciences is the fastest growing staffing organization specializing in Clinical Research and Life Sciences placements for all the major health systems and research organizations throughout the country. Medix is looking for a candidate with a Bachelor's degree and 5+ years of Sterile injectable manufacturing experience
Requirements:
Degree: BS Degree
Years of Exp: 5+ years of pharmaceutical experience with aseptic techniques experience
Industry Exp: Sterile injectable pharma experience
Skills and/or Certs: SOP Creation experience (not just revisions - need to have created from scratch)
Position Summary: Location: Rochester, MN 55902 Pay: 75-90k depending on experience Hours: M-F 1st shift with 2nd shift flexibility Duration: direct hire
Position Description: • Leads and supports other team members in a fast-paced manufacturing environment
and setting, to include backing manufacturing goals, standards, mindsets, and behaviors
both on and off the manufacturing floor. • Ensures strict adherence to quality, safety, regulatory guidance, and written procedures
in the manufacturing of final drug products in accordance with CFR (CGMP) guidelines,
FDA, OSHA, and MN DHS. • Performs routine cleaning of the manufacturing areas, setting up manufacturing
equipment, performing daily checks on various manufacturing equipment, and
operating of equipment in accordance with SOPs, cGMP, and aseptic technique. • Follows all written procedures, verbal instructions, and communicates effectively, both
written and verbally. • Performs documentation and calculations in accordance with SOPs and CGMP
complexity for various phases of radiopharmaceuticals. • Works cross-functionally with other team members such as R&D, quality, and safety to
develop and/or update SOPs for the manufacturing of radiopharmaceuticals • Participates and performs effectively in a team environment. Proactively interacts with
cross-functional departments such as quality and safety to ensure the operational
success of the manufacturing areas. • Demonstrates willingness to be flexible and adaptable to the needs of the department
and business. • Takes initiative to achieve personal and departmental goals with quantifiable business
results. • Ensures internal / external sponsor expectations are met or exceeded. • Coordinates manufacturing schedules, inventory management, equipment
maintenance, and training and development of other manufacturing technicians. • Works with Quality Assurance for investigations, deviations, root cause analysis, out of
specifications, and/or non-compliance investigations. • Performs other job-related duties as assigned.
Qualified candidates are encouraged to apply!We would love to discuss these positions with you further!