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Laboratory Application Scientist / Supervisor

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 QC Manager,

JOB SUMMARY:

The Laboratory Application Scientist ensures that all laboratory systems composed of equipment, instruments and computerized systems are properly maintained, qualified, calibrated and secured to be properly used by the laboratory users to ensure a high level of confidence with product results. Provide access management for each computer system, while ensuring data handling and data integrity meet internal SOP and FDA requirements. This position is partnered with the laboratory system owners and the IT group. Ensuring all laboratory systems are properly used in chemistry and microbiology laboratories and assisting laboratory staff with technical issues and training. Provides recommendations on efficiency, new technology and best practices in the QC laboratories.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES:

Laboratory Computerized Systems Management

Manage software upgrades and qualifications for all laboratory computerized systems

Manage user accounts and train technicians on existing software

Assist and oversee with the site LIMS system

Create instrument control methods

Perform system audit trails reviews

Ensuring compliance with data integrity policies and FDA regulations

Manage contracted external vendors

Laboratory Systems Calibration, Maintenance and Qualification

Manage all scheduled updates with the laboratory scientists and supervisors

Manage maintenance interventions; establish a maintenance contract with the vendors

Perform testing or supervise the execution of testing

Manage external vendors

Write and/or evaluate deviations, SOP, protocols and reports

Oversee Metrology program for the QC group

Verify and sign vendor qualification protocols, validation reports and metrological reports

Write requalification paperwork

Follow GMP guidelines for documentation, validation and calibration

Quality requirements and improvements

Ensure the working condition of equipment and participate in the investment budget

Order new equipment after evaluation and approval by the QC Manager

Establish user requirement specifications for systems replacement

Manage requests for quotations and orders for the purchase and repair of laboratory equipment

Participate in audits and inspections

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)

Analyze the processes in place and the working methods in place, and propose improvements to improve compliance and / or efficiency

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

Your profile

QUALIFICATIONS/EXPERIENCE:

5-10 years of laboratory experience, in development, or QC laboratories, including validation, qualification and calibration purposes

Software and instruments experience, especially HPLC, LCMS, ICP and GC knowledge

Quality Control/Assurance and GMP experience preferred.

Technical knowledge to review and analyze test results

Ability to write and provide input for deviations, investigations and CAPA’s as needed

Laboratory or analytical development experience in pharmaceutical manufacturing or medical device background required

SPECIFIC SKILLS:

Must have previous experience in cGMP environment

Knowledge of LIMS use and development

Strong knowledge in instrument and software validation

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.

Computer Skills:

Basic Outlookskills as evidenced by creating and sending messages, working with address books, message handling, creating and using personal folders, scheduling appointments, working with meeting requests and managing tasks.

Intermediate Microsoft Wordskills as evidenced by the ability to produce basic business letters and simple tables and charts; as well as check spelling, set tabs, change page orientation, sort, save, open and organize electronic files; as well as create moderately complex documents containing tables and graphs, and ability to mail merge documents, apply page setup functions (margins, page numbers, footers, headers), create an index and/or table of contents, use search & replace, print labels and envelopes.

Intermediate Excelskills as evidenced by the ability to use workbooks, create simple formulas, insert and delete data, create and edit charts, filter and sort lists, and format data, link data, create and edit charts, change page orientation, add headers and footers, filter and sort lists, format data, insert rows, enter and sort data and produce graphs and charts.

PHYSICAL REQUIREMENTS/ENVIRONMENT:

Frequent sitting - 60% of the day, standing - 15% of the day, and walking/moving about - 25% of the day.

Finger dexterity required to operate instrumentation, equipment, and computer functions

Visual requirements of having the ability to read the equipment, computer screen, documents and discern color and shading variations.

Occasional lifting/moving of up to 40 lbs.

SCOPE OF DECISION MAKING:Decisions require advanced analytical judgment. Plan and perform diversified duties requiring knowledge of a particular field and the use of a wide range of procedures. Involves the exercise of judgment in the analysis of facts or conditions regarding individual problems or transactions to determine what action should be taken within the guidelines or standard practice.

LEVEL OF SUPERVISION PROVIDED:Project direction of other employees performing the same or directly related work, including assigning, reviewing, checking work, mentoring and coaching. Direct supervision of 1-2 people.

INTERNAL / EXTERNAL CONTACTS:Regular inside and outside the organization: Requires regular contact with subordinates and/or other departments, and contacts with individuals outside the organization.

Compensation range

82,000.00 - 92,000.00 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!