Pharmaceutical Quality Program Associate Manager
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Job Location:
Rensselaer, NY - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
- Work in a GMP-regulated environment to provide and assist in the implementation of quality-related activities.
- Develop a comprehensive set of quality metrics aligned with organizational goals and industry standards. This involves collaborating with stakeholders to identify key performance indications (KPIs) and defining measurable objectives.
- Collaborating with cross functional client Quality and other PSS site team.
- Collecting data from various process areas defect reports and performance metrics. Analyze the data to identify trends patterns and areas of improvement.
- Generate regular investigation training reports to provide visibility into quality performance. Manage quality improvement activities meetings and other activities supporting the work of the departments.
- Presenting and Communicate quality related metrics trends and insights to stakeholders at various level of the organization. Present findings in meetings reviews and reports to facilitate informed decision making.
- Evaluate and managing resources and task- understanding department needs to evaluate resources needed by implementing the Capacity model system and cross-functional training.
- Assist with other aspects of quality improvement including administrative and operational support as needed.
- Drive continuous improvement efforts through monitoring/evaluation of site systems & processes aligned with GMP and FDA requirements. To ensure adherence with quality standards and best practices.
- Evaluate the thoroughness and effectiveness of the training program. Foster a culture of quality awareness and continues improvement throughout the organization.
- Provide oversight of systems to ensure compliance with internal policies procedures and guidelines.
QA Essential Duties and Responsibilities:
- Applies GMP/GLP in all areas of responsibility as appropriate
- Demonstrates and promotes the companys vision
- Regular attendance and punctuality
- Ensure that the quality policy program is understood implemented and maintained at all levels of the organization; identify prevent or correct any departures from the quality system
- Perform work for both routine and non-routine work as specified by separate and applicable technical job descriptions for individual
- Develop and implement operational improvements
- Supervise others in performing clients service requirements
- Coach train and develop others within the group with respect to their personal development and effective implementation of operational improvements
- Coordinate workflow and perform daily monitoring to meet TAT
- Conduct semiannual performance reviews interview applicants keep training records up to date for assigned employees perform succession planning in preparation for growth
- Confront and address problems concerns and performance issues
- Coach and develop individuals and teams to maximize performance
- Foster motivation and morale
- Monitor and approve employees time worked through time-entry system
- Support and promote company policies and procedures
- Expand self-awareness and develop leadership skills as defined; attend applicable leadership training based on identified needs
- Perform and/or assign other duties as requested to ensure the smooth operations of department
Qualifications :
Education Requirements:
- Preferred Masters or Minimum Bachelors degree in a Science / technical field such as Pharmacy Biology Chemistry or Engineering.
Basic Minimum Qualifications:
- Minimum of five years experience in the pharmaceutical industry and/or FDA experience Quality Assurance/Compliance.
- Experience having ownership over quality programs and systems
- Professional leadership experience
- Strong knowledge of global regulatory and cGMP requirements industry best-practices
- Strong familiarity with production operations.
- Strong leadership project management and technical writing.
Additional Information :
The position is full-time Monday-Friday from 8 am-5 pm. Candidates living within a commutable distance of Rensselaer New York and the surrounding areas are encouraged to apply.
- Excellent full-time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holiday
- Targeted Compensation: $80000 - $95000
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Crisis Management
- Microsoft Word
- Office Experience
- Conflict Management
- Constant Contact
- Microsoft Powerpoint
- Research Experience
- Salesforce
- Administrative Experience
- Public Speaking
- Google Suite
- Writing Skills
About Company
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more
