Compliance Specialist II
Who we are?
We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives to as many people as possible.
With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees.
Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 280 employees.
Your role
The Compliance Specialist II conducts and supports problem investigations (deviations), change controls and final release of finished products. The Compliance Specialist II is responsible to manage the receipt, and investigation of product complaints. Ensures that all product complaint investigations received are appropriately investigated and concluded per the company’s complaint handling procedure. Monitors complaint activity and provides suggestions to appropriate company authorities to modify existing processes based upon pattern and related analyses.
This position will serve as a frequent inter-organizational contact and will represent the QA department on teams as well as routinely interact with our customer’s QA representatives. Will review and approve a wide variety of GMP related documents and provide appropriate feedback when necessary. This position interacts with manager and director levels of management in all departments in developing solutions and providing timely and accurate communication.
• Supports and provides final review and approval of problem investigations (deviations) and change controls. The CS II is responsible for ensuring the investigation contain the appropriate level of detail.
• Receives and investigates market’s product complaints. Investigations include, but are not limited to, review of batch records, retains, associated deviations/complaints and other data as identified.
• Identifies additional internal resources required for thorough investigations; works with those individuals to ensure the process is handled with the appropriate level of detail.
• Works with the appropriate discipline to identify corrective/preventative measures necessary for each observation made for improvement and to align processes to consistently manufacture quality products.
• Coordinates documentation required at the completion of investigations; pulls all materials together into a concise summary that thoroughly documents the conclusions of the investigation. This could include, but is not limited to, submitting the complaint for final QA approval in the system, and assistance in preparation of a CAPA.
• Provides appropriate response to customer.
• Analyzes complaints to identify trends
• Provides complaint reviews in support of the annual product review system, ensuring on time issuance to support publishing of APR’s within the required timeframes outlined in site procedures.
• Ensures the development, documentation and implementation of standardized processes for key business functions. Develops quantitative techniques to monitor process performance.
• Evaluates effectiveness of SOP, identifies changes that would enhance the process, and ensures that all change control documentation is implemented.
• Identifies and implements ways to streamline and improve efficiency while maintaining process effectiveness. Challenges the way it has always been done.
• Utilizes understanding of regulatory environment and industry trends to identify ways to improve process quality and compliance.
• Identifies the impact of available technology on business processes and ensures that it is used to maximum advantage.
• Ensures stakeholders are appropriately trained on the process and any process changes.
• Maintains knowledge of applicable regulations and company procedures. Provides quality leadership and technical expertise on quality activities, including leading or supporting process improvement initiatives.
• Provides quality guidance to the organization for compliance issues.
Bachelors’ Degree Chemistry, Biology, Pharmacy, Health Science or Related Field, or equivalent experience
Minimum 5 years Quality Assurance experience in FDA regulated environment
• A comprehensive understanding of current regulatory requirements and ability to interpret them. Good teamwork and project management skills (including the ability to lead teams).
• Must be able to recognize situations where there is a potential impact on product quality, safety, identity and purity.
• Traditional office environment, with frequent visits to other areas of the facility, including production areas, loading docks, and laboratories.
• Must be able to work on a computer for extended periods of time.
• Must wear safety glasses and other protective items as required.
• Sitting 75% of the day; standing or walking 25%.
• Bachelors’ Degree Chemistry, Biology, Pharmacy, Health Science or Related Field, or equivalent experience
• Minimum 5 years Quality Assurance experience in FDA regulated environment
• A comprehensive understanding of current regulatory requirements and ability to interpret them. Good teamwork and project management skills (including the ability to lead teams).
• Must be able to recognize situations where there is a potential impact on product quality, safety, identity and purity.
• Traditional office environment, with frequent visits to other areas of the facility, including production areas, loading docks, and laboratories.
• Must be able to work on a computer for extended periods of time.
• Must wear safety glasses and other protective items as required.
• Sitting 75% of the day; standing or walking 25%.
Learn more about us:
We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.
Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.
We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.
We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.
Join us and make a difference!