Specialist II, Manufacturing-Inspection (Days)

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.

For more information, please visit www.resilience.com

Position Summary & Responsibilities

The Manufacturing Specialist II uses expert knowledge of compliance and GXP manufacturing process to manage investigation and improvement initiatives within the Inspection team. This role reports to the Manager, Visual Inspection SME. The specialist will focus on tasks related to defect creation/kitting, operator training/qualification program, investigations, defect data analysis, and supports improvement activities (5S, participate in problem-solving and Kaizen events, manual data collection) in accordance with cGMPs.

Primary 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 manual visual, cosmetic, and physical inspection of material. Promptly escalate concerns to Lead and Manager/Supervisor as needed.

• 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.

• Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.

• Assist with creating and maintaining visual inspection standards

• Assisting with investigations and resolving visual inspection issues

• Collaborating with cross functional teams to address challenges

• Operate defect equipment in accordance with EHS and Quality standards

• Perform inventory control and reconciliation activities, which may require the use of SAP in a limited role.

• 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.

• Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, waste handling, chemical handling, and spill controls. Report all discrepancies to Manager

• Be flexible in training and support other Filling functions as needed

• Perform all other assigned duties with minimal supervision under the direction of the Manager

• Acquire and maintain all required certifications and qualifications for the assigned work area

• 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

• Some overtime may be required with minimal advance notice to support business needs

• Candidate should possess the ability to work in and adapt to a changing/demanding environment

Minimum Qualifications

• Significant experience in a pharmaceutical or cGMP regulated environment

• Good attention to detail is required. Individual must be capable of keeping accurate records and performing mathematical calculations.

• Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.

Preferred Qualifications

• High school graduate, vocational school graduate or equivalent

• Prior production experience

• Prior Aseptic Manufacturing Experience

• Knowledge of cGMPs and FDA policies/procedures

• Experience working in a LEAN manufacturing environment

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $28.50 - $43.00 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.