AMA IV - Manufacturing Technical Specialist (2nd, 3rd, or Weekends)

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 AMA IV - Manufacturing Technical Specialist executes technical support activities for GMP Manufacturing Operations in a multi-product, Fill/Finish CMO facility including activities related to compliance, quality, targeted innovation, and plant performance and success. Specialist will be responsible for the production in one of two functional areas: Aseptic Filling or Formulation/Prep.

Non-Negotiable Requirements:

• Bachelor's degree in life sciences or equivalent training and/or experience.
• Three to five years of relevant experience in pharmaceutical manufacturing or a laboratory environment is required
• Previous experience in a CMO and/or sterile pharmaceutical manufacturing.
• Must have proficient computer skills in Microsoft Word, Excel, and Outlook.

Responsibilities Include (but are not limited to):

• Lead or execute implementation of targeted new technologies and procedures.
• Transfer technical processes from the MSAT and validation groups to the production floor with the assistance of the Production Team (Supervisor, Leads, and Trainers). Will require flexibility of schedule to ensure personnel are on-site during execution of critical operations.
• Responsible for ensuring SOPs and MBRs are followed in their functional area.
• Assess, evaluate, and provide immediate corrective actions for GMP discrepancies and intra batch process monitoring, analysis, and reporting.
• Develop technical expertise to ensure equipment in functional area is maintained and operational by completing or assisting with the completion of preventative maintenance activities with the maintenance department.
• Filling Technical Specialist - Responsible for the changeover and testing of equipment between different product configurations for high-speed filling lines in an isolator environment, and all other activities downstream of the sterile filter.
• Formulation/Prep Technical Specialist - Responsible for overseeing and executing formulation activities including but not limited to setup, thaw, weigh/dispense, compounding, dilution, and all other activities upstream of the sterile filter.
• Maximize the success rate for production operations by instituting programs to minimize human error, mechanical failure, contaminations, and procedural error.
• Support strategic plans for process and plant improvements to increase efficiency and manage costs.
• Work with Tech Transfer and Project Management teams to transition products through the product development timeline.
• Implement and review operational documentation systems within Manufacturing, Operations and Process Development. Main responsibilities include authoring and implementation of manufacturing procedures and batch records. Drafting SOPs, addressing comments, incorporating edits, and issuing final drafts for approval.
• Effectively collaborate with other team members, production operators, engineers, microbiologists, analytical chemists, project managers, and senior management.
• Assist engineering and validation with implementation, commissioning, and validation of clean room spaces and process equipment.
• Take corrective action by thinking creatively, problem solve, and develop innovative solutions based on sound scientific analysis.
• Initiate revisions to cGMP procedures, and master batch records as applicable.

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.