Campus Pride Jobs

Lab Application & Quality Control 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 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 - 102,000.00 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!