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Stability 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 stability supervisor is responsible for the stability management for the products released on the market from the SOW with the customers until the lab release, including the stability report, before official release by QA. With a team composed of 3 analytical scientists, the stability supervisor should inform the management in case of OOT and OOS results, has to investigate and propose CAPA, and has to manage all types of deviations within the stability scope. The laboratory and equipment will be shared with the others laboratory teams, as well as the standards, reagents, glassware, logbooks. Then, as part of the laboratory, the stability supervisor will interact with the other supervisors, and will have to manage the team to respect the rules. At the origin of revenues, the stability supervisor will in charge to propose a budget, manage the costs.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES:

Employee Development & Training

Ensure that the team's training/accreditation is in line with its missions.

Manage the team's schedule via ADP software

Conduct annual appraisal interviews to assess team development and performance

Define action priorities in relation to means, resources and deadlines

Develop team skills and autonomy

Stability Studies Management

Monitor on-going stability planning and initiate sampling requests for on-going products

Warranty that all studies are conducted according to the scheduling and make sure that the testing are done on time

Propose and write and sign stability protocols according to customer and regulatory requirements

Propose and write the SOW according to the regulations in place and submit them to customers

Register new studies in the planning

Warranty that unplanned stability program is properly integrated in the planning

Work closely with the others laboratory supervisors to integrate your testing in the release testing planning and share with them the space, reagents, standards, glassware…

Write and sign the stability reports prior review by your manager and prior QA approval

Write the tests methods and approve the methods loaded the LIMS, if applicable

Verify the analytical cards

Follow up the trends and inform your management and QA in case of OOT and OOS results

Investigate with your scientists the deviations, OOT and OOS results according to the procedure in place. Approve the deviations and investigations as supervisor in charge.

Write and sign the stability reports prior review by your manager and prior QA approval

Communicate with the customers for stability purposes and participate to the meeting, if necessary, as subject matter expert

Follow up the costs and billing

Establish and report the budget for the year (costs and revenues) and share revenues on a monthly, quarterly and yearly basis with management at the beginning of each month

Stability Chambers Calibration, Maintenance and Qualification

In relation with the laboratory instruments supervisor, define and update, if necessary, the calibration, maintenance schedules for the stability chambers

Plan the interventions with suppliers and work with them, when applicable

Purchase consumables needed for these operations

Perform tests or supervise the execution of tests and issue appropriate reports

Verify and sign metrological reports from our subcontractors

Write and/or evaluate deviations

Provide calibration labels

Verify and sign vendor qualification protocols and reports and/or draft protocols in-house

Quality requirements and improvements

Keep your documentation up to date

Participate in the EP and USP surveys to update the methods (lead and / or participate)

Participate in audits and inspections and propose CAPA plan including timeline, and execute them on time

Manage all your CAPA on time

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

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:

Computer Skills:

Basic Outlook skills 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 Word skills 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 Excel skills 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.

Your profile

Bachelor’s Degree in Science, preferably in Chemistry or closely related field is required.

5-8 years’ experience in stability program coordination or interpretation of stability data in pharmaceutical manufacturing or medical device manufacturing.

Quality Control/Assurance, Stability and GMP experience preferred.

Prior Supervisory experience required

Must have previous experience in cGMP environment

Compensation range

90,000.00 - 110,000.00 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!