Location: Buena, NJ
Reporting Relationships: Commercial stability team
- Manage routine operations and oversee scheduling commercial stability testing.
- Provide ongoing quality control support to all departments as required. Provide timely communication to internal and external customers.
- Actively participate in activities required by the regulatory authorities in order to remain compliant.
- Ensure that laboratory investigations associated with commercial stability are reviewed, approved, and closed within thirty (30) day,
- Implement and maintain a system so that commercial stability is never missed.
- Develop standards and maintain quality metrics for commercial stability testing adherence.
- Review approve and train on new and revised quality documents (specifications, analytical test methods, SOPs, protocols, technical documents, etc.) in support of product testing and continued improvement to the Quality System.
- Keep upper management informed of all key quality findings and issues.
- Use all electronic systems as needed within the department.
- Assumes other activities and responsibilities from time to time as directed.
- Provide leadership for quality operations, to implement clear policies, processes, and metrics in line with business strategy and regulatory requirements that drive consistency and compliance with quality standards.
- Develop a highly engaged, self-empowered and capable team through goal setting, mentoring, talent development activities, and reviews.
- Supporting all investigations by ensuring compliance to procedures; performing root cause analyses; performing trend analyses; developing and implementing corrective actions; improving procedural efficiencies.
- Performing product, data, and trend analyses to support organizational needs and continuous improvement activities.
- Drive continuous improvement objectives and initiatives. Leads or participates in quality improvement projects either independently or through the Quality process improvement manager.
- Other duties as assigned.
- Education: Bachelor’s degree in Chemistry, Engineering or other Physical Sciences
- Minimum 5- 8 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:
- Talk and hear.
- Stand and use cleaning and sanitization chemicals (LpH, Vesta-Syde, Spor-klenz, Sodium Hypochlorite solution, etc.), as part of the daily cleaning/sanitization duties.
- Must be able to wear a PAPR and a Full-face respirator and other related PPEs.
- Must occasionally lift and/or move up to 40 pounds.
- Frequently required to visually inspect product and must have the ability to see clearly, (20/20 corrected vision), at close range, (20 inches or less), and at a distance of 20 feet or more.
- Employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
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.