Location: Buena, NJ
The shop floor inspector is responsible for ensuring that all product and processes conform to the approved GMP documentation as well as all relevant regulatory and statutory requirements. This individual will be on the shop floor continuously reviewing completed GMP documents, inspecting the state of the facility, auditing processes, and remediating any non-conformances observed.
Reporting Relationships: Individual contributor
- Performs GMP walk through inspections to ensure compliance with statutory and regulatory requirements.
- Coaches, mentors, and trains any individual that is not performing a task in accordance with the approved documentation.
- Real time batch record review and correction on the floor.
- Ensures that all logbooks and other GMP documents are signed and completed extemporaneously.
- Partners with operations and other departments to drive proactive improvements into every area of the organization.
- Record all observations, non-conformances, and ideas on a daily basis and submits them to his/her supervisor
- Confirms that all in-process inspections are occurring and that the required quantities are supported by the appropriate AQL calculations.
- Other duties as assigned.
- Education: Bachelor’s degree in Chemistry, Engineering or other Physical Sciences or equivalent
- Minimum 1-5 years of experience in medical device and/or pharmaceutical QA or QC role
- Working knowledge in the quality systems for the medical device and/or pharmaceutical industry
- Working knowledge in FDA 21 CFR Parts 11, 210, 211 and 820 and ICH quality system requirements
- Ability to work collaboratively in a professional and effective manner across all Teligent departments
- Strong project management skills and problem-solving skills
- Working knowledge of risk management
- Strong leadership skills:
- Ability to delegate and verify
- Ability to manage and prioritize multiple tasks
- Ability to guide and motivate personnel
- Ability to plan and organize available resources and activities in-order to reach predefined goals
- Awareness of inter-personnel relationships in the company
- Experience in using computer programs (MS Word, Excel, and Access)
- Strong verbal and written communication skills
- While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.