Quality Control Manager - Rochester, United States - Unifin SAS
Description
Quality Control Manager
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
Reporting to the
Quality Director,
The Quality Control Manager oversees all activities relevant to thequality control in a pharmaceutical Contract Development and ManufacturingOrganization, from the incoming inspection of the materials, through thetesting (microbiology and chemistry) of the fluids, raw materials, bulks andfinished products, to the stability testing and certifying the products on themarket meet with the specifications through the expiration date.
That includes the resources management (employees, instruments, externalcompanies, standards & regulations, budget and costs), and the maintenanceand/or calibration of the equipment and software used in the laboratories.
As a member of the quality team and GMP organization, the QualityControl Manager must meet the regulations in place for sterile and non-sterileproducts and ensure that the Quality Control department is able to proposecontinuous improvement.
This position interacts with manager and director levels of managementin all departments in developing solutions and providing timely and accuratecommunication.
As a Quality Control Manager, frequent interactions will occurwith our customers including documentation approvals, deviations, changecontrols and various meetings and business reviews.
The Quality Control Manager will serve as themain QC contact for customers regarding deviations, change controls, audits,and any other quality control concerns.
ESSENTIAL FUNCTIONS /RESPONSIBILITIES:
EmployeeDevelopment & Training
Define the staffing and training needs of the Quality Control department to carry out the industrial and commercial plan
In collaboration with managers, ensure the implementation of the annual training plan
Ensure the adequacy of the team's qualification in relation to the missions
Develop the team's skills and autonomy
Oversee staff training on all lab equipment and ensure all training for each device is up to date
Define priorities for action, in relation to means, resources and deadlines
Conduct annual performance evaluations and assess the development and performance of your team
Formalize and monitor quantifiable objectives for the analytical and microbiology control activities.
CostManagement
Establish relevant indicators and control ranges in a budget process to be validated by management
Create quarterly activity reports and justify any deviations observed in relation to the budgetary assumptions
Anticipate and justify all resources needed for quality department (employees, equipment, instruments, software)
Testing(Chemistry & Microbiology)
Deliver certificates of analysis (raw materials, packaging components, finished products) to the customer quality department within standard deadlines
Evaluate the technical and document implementation of any new analysis method implemented and anticipate the commercial launch of development projects
Ensure all methods and specifications are updated in the LIMS
As a back-up to team leaders, accept or reject raw materials and packaging components within standard deadlines
Collaborate with logistics and production during Planning Meetings
Prioritize analysis according to the production master plan
Optimize your analysis by anticipating reception and production schedules
Control the flow and management of analytical samples
Oversee the monthly verification of reagent and standards expirations
Be the analytical expert by mastering the different analytical and control methods and by supervising the investigations
Carry out stability studies for which the site is responsible
Specifically, for Media Fill tests, oversee staff training, readings, sterility checks, reconciliation.
Ensure theapplication of procedures according to the standards described (FDA Guidance, GMP,etc.) and carry out sterility identifications and tests on time
Equipment& Instrument Management
Monitor the laboratory's equipment (status and validity limits) in collaboration with equipment experts
Plan equipment checks according to the VMP using dashboards
Ensure the completion of the qualifications (initial and annual) of the equipment
Maintain available equipment both in-house/outside sources
Define specifications and comparative files justifying the orientations
Create SOPs on Control Laboratory devices
Define all access management to systems, and software
QualityRequirements & Improvements
Ensure the drafting of investigations in the event of Deviations (OOS, OOT, deviations) in Compliance with the requirements of Quality Assurance and health authorities
Write expert and validation reports in the analytical field
Perform internal audits and participate in external audits for analytical subcontractors
Master the laboratory's documentary system by distributing procedures, keeping logbooks, and recording documents
Develop and manage processes to ensure compliance and data integrity requirements are being met.
Active surveillance of the USP & PE requirements to ensure timely updates of methods and collaboration with QA..
Implement critical corrective actions of the quality CAPA within the established and previously agreed deadlines
Define continuous improvement objectives through action plans translated into numbers
Implement and maintain raw material reduction testing conditions
Implement cross-functional optimization plans (development, purchasing, etc.) or specific to the Control Laboratory
Gather the results of the raw materials concerned, the fluids, the environment
Analyze trends, write reports and propose and engage all necessary action plans once approved by QA. Collect data to carry out annual product reviews
Health& Safety
Comply with the implementation of PPE and procedures
Apply a controlled hazardous materials management policy
Comply with the rules of handling and storage and the appropriate identifications
Enforce a policy to control exposure to chemical substances by laboratory employees
Develop and maintain a 5S approach to avoid safety issues
Manage the wastes according to the safety policies in place
Your profile
EDUCATION &
EXPERIENCE:
Bachelor's degree required; Masters preferred
10-15 years in an FDA regulated environment; CMO preferred
5-10 years of supervisory experience required
Prior Quality Control experience in manufacturing, facility operation, laboratory compliance and quality systems.
Compensation range
115, ,000.00 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.
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