Customer Quality Specialist - Short Term Contract

Unifin SAS • Rochester, NY

1d • $43 - $60 • Onsite

About The Position

Customer Quality Specialist - Short Term Contract
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 300 employees.
Your role
Reporting to the QA MANAGER,
SHORT TERM CONTRACT (Approx. 3 Months) - This will be an contract position payrolled through a staffing agency and is expected to last approx. 3-4 months to cover a department leave. Full-time, on-site.

JOB SUMMARY:
The Customer Quality Specialist II conducts and supports problem investigations (deviations), change controls and final release of finished products. Customer Quality Specialist II is responsible to manage the receipt, and investigation of product complaints. Ensures that all product complaints received are appropriately investigated and concluded per the company’s complaint handling procedure. Monitors complain about activity and provides suggestions to appropriate company authorities to modify existing processes based upon pattern and related analyses. Serves as department point of contact for updates and managing chain of communication related to department prioritization.

This position will serve as frequent inter-organizational contact and will represent the QA department on teams as well as routinely interacting with our customers’ 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.

Requirements

• Bachelor’s degree in chemistry, Biology, Pharmacy, Health Science, or related field.
• A minimum 5-year Quality Assurance experience in FDA regulated environment is preferred.
• Degree requirement may be substituted with a minimum of 8-10 years of Quality Assurance experience in FDA regulated environment at an equivalent level.
• 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.

Responsibilities

• Supports and provides final review and approval of problem investigations (deviations) and change controls. 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 APRs within the required times 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.

Benefits

• 100% employer-paid medical premiums (a $2,000–$6,000+ annual value)
• 401(k) contributions: 6% match plus an additional 4% company-funded contribution
• HSA contributions with wellness incentives

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level