Operations Technical Specialist I

Description

Quality, Service, Collaboration, Courage. Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded culture? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day.

Overview of this Position:

The Operations Technical Specialist will execute routine technical support activities for GMP Manufacturing Operations across multi-product, Manufacturing, Fill, and Finish CDMO facilities. Activities include cross-functional deviation investigations, CAPAs, AIs, targeted innovations, audit support, and overall plant performance. This position supports all GRAM sites and works closely with Quality as well as Operations, Continuous Improvement, Engineering, MSAT, and Project Management to support site objectives.

Non-Negotiable Requirements:

• Bachelor's degree in life sciences or equivalent training and/or experience is necessary.
• 3-5 years of relevant experience in pharmaceutical manufacturing is required.
• Strong skillset in root cause analysis, technical writing, and CAPA in a GMP environment and/or related LEAN/six-sigma experience.
• Must have proficient computer skills in Microsoft Word, Excel, and Outlook.

Preferred Requirements:

• Previous experience in a CMO and sterile filling, manufacturing, and/or fill finish environment.

Responsibilities Include (but are not limited to):

• Exhibit Complex Conflict resolution and problem-solving skills in a cross functional setting.
• Work closely with respective team members from Operations, Engineering, Maintenance, Project Management and Quality to ensure all documentation (and respective data) is gathered in an expeditious manner for timely completion of deviation investigations.
• Ensure appropriate risk analysis, root cause, and corrective action tools and identification are used for all deviation investigations.
• Author and revise site procedures in a timely manner to address CAPA and corrective actions for deviation investigation and/or site continuous improvement projects.
• Assist in implementation of targeted new technologies and procedures.
• Assess, evaluate, and provide immediate corrective actions for GMP discrepancies and intra batch process monitoring, analysis, and reporting.
• Serve as first line of defense for all operations excursions, GMP lifecycle management of execution level process data, providing for unit operation (i.e., formulation, manufacturing, sterile filling, inspection/labeling).
• Support strategic plans for process and plant improvements to increase efficiency and manage costs.
• Effective cross-functional collaboration with Quality, Continuous Improvement, MSAT, AMAs, MPEs, SCM, Operations Supervision, and Management.
• Assist engineering and validation with implementation, commissioning, and validation of clean room spaces and process equipment as well as inspection and packaging process equipment.
• Take corrective action by thinking creatively and problem solving to develop innovative solutions based on sound scientific analysis.
• Initiate revisions to cGMP procedures, and master batch records as applicable.
• Initiate daily, weekly, and monthly site quality metrics and trend reviews.
• Assist in the review and approval of Validation documents and site change controls.
• Work an on-call schedule for technical support and site deviation analysis.

Full job description available during formal interview process.

What Sets GRAM Apart from Other Employers:

MEDICAL BENEFITS starting day 1: Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying for 75% of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!

Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!

PTO: Full-time employees accrue up to 13 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!

WELLNESS TIME OFF: Employees earn 1 hour of time off for every 30 hours worked to use how you choose.

PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!

PAY: Depends on Experience and is discussed during the interview process.