Specialist I, Manufacturing-Inspection (Days)

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Position Summary & Responsibilities
The Manufacturing Specialist I 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 qualification program, 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.

Other Responsibilities

• 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.

Optional Training / Responsibilities

• 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.

Competencies & Job Requirements:

• 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 Process Execution 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/shift adjustment may be required with minimal advance notice to support business needs

Minimum Qualifications

• 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.
• Ability to work with a variety of hand-held tools and different glass types.
• Good attention to detail is required. Individual must be capable of keeping accurate records and performing mathematical calculations.

Preferred Qualifications

• High school graduate, vocational school graduate or equivalent
• Prior production 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.