Specialist, Manufacturing

Resilience•Blue Ash, OH

7d•$26 - $39•Onsite

About The Position

A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. This position will require working in various Controlled/Non-Classified areas. The Technician performs a variety of manufacturing tasks (operates equipment, performs visual, cosmetic, and physical inspection, line clearances, OEE data collection and completes batch record entries) and supports improvement activities (5S, participate in problem-solving and Kaizen events, manual data collection) in accordance with cGMPs.

Requirements

Prior experience in a pharmaceutical or cGMP regulated environment
Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.
Good attention to detail is required. Individual must be capable of keeping accurate records and performing mathematical calculations.
Ability to work with a variety of hand-held tools and different glass types.
Must be able to pass an eye exam
Specific visual skills (i.e., extensive reading or computer use, normal color vision, depth perception, or visual acuity)
Specific hearing requirements
Interpreting sounds and associated meanings at volume levels consistent with interpersonal or group conversations; interpreting letters and numbers when viewed on a computer screen, monitor, reports and other documents; identifying and distinguishing colors; seeing with 20/20 (or better) vision, with or without correction.

Nice To Haves

High school graduate, vocational school graduate or equivalent
Prior production experience
Experience working in a LEAN manufacturing environment
Knowledge of cGMPs and FDA policies/procedures

Responsibilities

Perform the duties of using the approved tools to create defect units that will be used in Inspection defect kits.
Conduct evaluations on other team members for training qualifications.
Perform cleaning and housekeeping for assigned areas as required to maintain a cGMP environment.
Perform GMP documentation entries. Maintain records and/or logs as required in the performance of job responsibilities. This will include mathematical computation where needed.
Knowledge of product security controls and kit reconciliation.
Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, human safety, material handling, waste handling, chemical handling, and spill controls. Report all discrepancies to process Manager.
Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines. Be familiar with “Material Safety Data Sheets” for area chemicals.
Obtain knowledge to be able to print off SOP’s/Forms via ECMS.
Review process documents such as operational SOPs, forms and batch records for accuracy. Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise.
Assist with creating and maintaining visual inspection standards.
Assisting with investigations and resolving visual inspection issues.
Collaborating with cross functional teams to address any challenges.
Operate defect lab equipment in accordance with EHS and Quality standards.
Perform all other assigned duties with minimal supervision under the direction of the Manager.
Capable and motivated to learn new skills and develop new capabilities on an on-going basis to contribute to the success of the Inspection Team.
Ability to work effectively in a team environment.
Candidate should possess the ability to work in and adapt to a changing/demanding environment.
Some overtime may be required with minimal advance notice to support business needs.
Support lean activities and process improvement work such as performing 5S in the work area, participating in problem-solving, and manual tracking of performance data for OEE and process improvement analysis.
Perform all other assigned duties with minimal supervision under the direction of the Manager or designee as needed.
Obtain cold room training/access to be able to transfer materials in and out of the cold rooms.
Take proper training to become certified trainer on assigned process tasks.