Finishing Technical Specialist (1st/2nd/3rd Shift)

Description

Overview of this Position:

Responsible for executing technical support activities for GMP Finishing Operations in a multi-product, Fill/Finish CDMO facility. Activities include cross-functional deviation investigations, CAPAs, AIs, targeted innovations, audit support, and overall plant performance. This position will work closely with Quality as well as Operations, Continuous Improvement and Project Management to support site objectives. This role may work overtime and/or an on-call schedule for technical supports and site deviation analysis, as needed.

Non-Negotiable Requirements:

• Bachelor's degree in life sciences or equivalent training and/or experience is necessary.
• 1-2 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.

Preferred Requirements:

• Previous experience in a CMO and sterile filling is preferred.
• Knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.

Responsibilities Include (but are not limited to):

• 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 is 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 implementations of targeted new technologies and procedures.
• Assist in audit checks for the building and equipment as necessary
• 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 manufacturing excursions, GMP lifecycle management of execution level process data, providing for unit operation (formulation, sterile filling, inspection/labeling).
• Support strategic plans for process and plant improvements in order to increase efficiency and manage costs.
• Stock PPE as necessary
• Maintain vision of the production floor and equipment.
• Send Technical Notes to update Maintenance and Management.
• Utilize eMaint to compare and verify calibration for equipment.
• Train employees on cleaning and corrective actions for equipment.
• Effective cross-functional collaboration with Quality, Continuous Improvement, MSAT, AMAs, Operations Supervision and Management.
• Assist engineering and validation with implementation, commissioning, and validation of 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.
• Initiates daily, weekly, and monthly site quality metrics and trend reviews.
• Assists in the review and approval of Validation documents and site change controls.

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.