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Lab Application - Rochester, United States - Unither Pharmaceuticals
Description
Lab Application & Quality Control SupervisorWho 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 Control Manager,
The Laboratory Application & QC Supervisor ensures that all laboratory systems composed of equipment, instruments and computerized systems are properly maintained, qualified, calibrated, secured to be properly used by the laboratory users while ensuring a high level of confidence with product results.
Provide access management for each computer system, while ensuring data handling and data integrity. This position partners as the laboratory system owner with the IT group.Ensuring all laboratory systems are properly used in chemistry and microbiology, while assisting laboratory staff with technical issues, and training on the systems.
Provides recommendations on efficiencies and all secured data.ESSENTIAL FUNCTIONS / RESPONSIBILITIES:
Laboratory Computerized Systems Management
Manage all software upgrades and laboratory computerized systems and qualification
Manage user accounts and train technicians on existing software, check access at regular intervals
Validate the excel calculations used in QC
Create instrument control methods
Perform system audit trails of the various systems in place
Ensuring compliance with data integrity requirements in the control laboratory
Manage contracted external suppliers for certain interventions
Laboratory Systems Technological Surveillance
Manage the proper functioning of each instrument and ensure all equipment complies with applicable standards
Establish user requirement specifications for systems replacement
Manage maintenance interventions; establish a maintenance contract with the supplier if it cannot be carried out in-house
Manage requests for quotations and orders for the purchase and repair of laboratory equipment
Order new equipment after evaluation and approval by the QC Manager
Ensure the condition of equipment and participate in the investment budget
Laboratory Systems Calibration, Maintenance and Qualification
Manage all scheduled updates with the laboratory scientists and supervisors, at least annually, to ensure calibration and maintenance specifications.
Perform tests or supervise the execution of tests and issue appropriate reports
Plan interventions with suppliers or perform checks according to the defined schedule
Manage external suppliers, when applicable
Sourcing consumables needed for operations
Verify and sign metrological reports from our subcontractors
Write and/or evaluate deviations
Providing calibration labels
Verify and sign vendor qualification protocols and reports and/or draft protocols in-house
Providing the pre-authorization and support to Lab Operations, as needed
Write requalification paperwork
Apply GMP training received
Quality requirements and improvements
Participate and support metered instrument updates, as needed
Participate in audits and inspections and propose CAPA plan timeline and ensure a timely execution.
Maintain the laboratory qualification/validation/calibration master plan
Lead or participate in working sessions and projects (laboratory projects, sites projects), after agreement of your management
Analyze the processes in place and the working methods in place, and propose improvements to improve the compliance and / or efficiency
Update by yourself all types of documents for your perimeter, and lead the execution of actions
Support the development of new products by participating in the development/validation/optimization of methods and by integrating new instruments
Health & Safety
Respect and ensure compliance with dressing and hygiene procedures
Respect and ensure compliance with safety instructions and various procedures
Ensure compliance with safety rules during interventions or when writing the various standards and procedures
Have an appropriate attitude that does not endanger your safety and the safety of others
Report any discrepancies or risks you may find
SPECIFIC SKILLS:
Must have previous experience in cGMP environment
Strong knowledge and interest in testing software
Ability to evaluate data, perform trend analyses, identity potential issues, propose and implement solutions.
Ability to comply with SOP's, cGMP's, HS&E requirements, and FDA, DEA, and OSHA regulations.
Ability to work independently or within a group project team setting.
Your profile
QUALIFICATIONS/EXPERIENCE:
Bachelors degree in Life Sciences preferred
5-10 years of laboratory experience, in development, chemistry or stability, including validation, qualification and calibration purposes
Software and instruments interests, especially HPLC and GC knowledge
Quality Control/Assurance, Stability and GMP experience preferred.
Technical knowledge to review and analyze stability test results
Ability to write and provide input for deviations, investigations and CAPA's as needed
Stability experience in pharmaceutical manufacturing or medical device background required
Compensation range
87, ,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.
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
