Customer Quality Specialist - Short Term Contract

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 patientsu2019 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 companyu2019s 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 customersu2019 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. ESSENTIAL FUNCTIONS / RESPONSIBILITIES: Investigations Reach Sound Conclusions and CAPAu2019s are Identified (60%) u2022Supports 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. u2022Receives and investigates marketu2019s product complaints. Investigations include, but are not limited to, review of batch records, retains, associated deviations/complaints and other data as identified. u2022Identifies additional internal resources required for thorough investigations; works with those individuals to ensure the process is handled with the appropriate level of detail. u2022Works 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. u2022Coordinates 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. u2022Provides appropriate response to customer. Trends Identified (15%) u2022Analyzes complaints to identify trends. u2022Provides 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. Effective & Efficient Processes (15%) u2022Ensures the development, documentation, and implementation of standardized processes for key business functions. Develops quantitative techniques to monitor process performance. u2022Evaluates effectiveness of SOP, identifies changes that would enhance the process, and ensures that all change control documentation is implemented. u2022Identifies and implements ways to streamline and improve efficiency while maintaining process effectiveness. Challenges the way it has always been done. u2022Utilizes understanding of regulatory environment and industry trends to identify ways to improve process quality and compliance. u2022Identifies the impact of available technology on business processes and ensures that it is used to maximum advantage. u2022Ensures stakeholders are appropriately trained on the process and any process changes. Guidance & Advice (10%) u2022Maintains knowledge of applicable regulations and company procedures. Provides quality leadership and technical expertise on quality activities, including leading or supporting process improvement initiatives. u2022Provides quality guidance to the organization for compliance issues. Your profile EDUCATION & EXPERIENCE: u2022Bacheloru2019s degree in chemistry, Biology, Pharmacy, Health Science, or related field. u2022A minimum 5-year Quality Assurance experience in FDA regulated environment is preferred. u2022Degree requirement may be substituted with a minimum of 8-10 years of Quality Assurance experience in FDA regulated environment at an equivalent level. KNOWLEDGE SKILLS & ABILITIES: u2022A comprehensive understanding of current regulatory requirements and ability to interpret them. Good teamwork and project management skills (including the ability to lead teams). u2022Must be able to recognize situations where there is a potential impact on product quality, safety, identity, and purity. Compensation range 43.00 - 60.00 USD The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations. A Smarter Total Compensation Package At Unither, your base salary is just the beginning. Our Total Rewards include: + 100% employer-paid medical premiums (a $2,000u2013$6,000+ annual value) + 401(k) contributions: 6% match plus an additional 4% company-funded contribution + HSA contributions with wellness incentives + And moreu2014because we invest in your health, your future, and your peace of mind. Itu2019s a package designed to reward impactu2014not just hours worked. More Than Just a Paycheck At Unither, we donu2019t just offer competitive hourly wagesu2014we also pay 100% of your medical premiums.That means no paycheck deductions for your healthcare, which can be worth an extra $1 to $3.50 an hour in your pocket compared to jobs where you pay part of the premium. 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

Created: 2026-02-02