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Quality Systems Specialist

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 300 employees.

Your role

Reporting to the Quality Systems Manager,

A. JOB SUMMARY:

The Quality Systems Specialist will provide support to the Quality Systems group at the Unither Rochester Site. One of the main responsibilities of the position is the oversight of the Rochester Site Change Control systems. The specialist will facilitate the change control committee meetings, training employees on the change control processes and provide coaching to the site employees on the change control process. In addition to the oversight of the change control process, the position will be responsible for managing the site risk assessment process including the identification of risk, evaluation of deficiencies, training and coaching on the risk process.. The Quality System Specialist will facilitate the site internal audit program and assist in regulatory agency inspections, and customer audits.

B. DUTIES / RESPONSIBILITIES:

Oversee the site change control system

•Evaluate the change control system and provide continuous improvement ideas

•Monitor the system to ensure that all stakeholder approvals, final approvals, actions items and closures progress according to timelines.

•Facilitate the weekly Change Control Committee meetings. Provide a plan for the upcoming week, ensure all necessary stakeholders are present, and drive for final approval of the change control.

Administer the site risk assessment process

•Identify risk and evaluate deficiencies while working with internal departments/business units for remediation.

•Develop into the Subject Matter Expert (SME) for the site risk assessment process. Provide risk assessment training to site personnel, create, review, and/or approve risk assessments.

•Ensure remediation activities identified during the risk assessments are progressed and completed.

Facilitate the self-inspections management process

•Perform risk analysis to determine the content and schedule of the annual internal audits.

•Formalize the audit schedule ensuring that all six systems in the inspection model are considered including quality, production, facilities and equipment, laboratory controls, materials, and packaging/ labeling.

•Ensure adherence to the audit schedule, audit reporting, classification of deviations, development of responses and the implementation of actions.

•Provide continuous training for the internal audit team and facilitate professional training when necessary.

Assist with regulatory inspections and customer audits

•Coordinate with area managers to ensure the site is “inspection ready” in each of the areas by monitoring the site during regular site visits

•Ensure adequate preparation for all regulatory inspections, customer, and internal audits to include documentation and site personnel.

•Support the “Back Room” activities during Regulatory Inspections, when required.

•Compose the formal responses to the audit observations with the assistance of area managers or designees.

•Ensure follow-up of the corrective action plans initiated after customer audits and regulatory inspections.

•Document all inspection activities within the TrackWise system according to required timelines.

Participate in Quality Systems Processes

•Review and approve all documents associated with the activities of the job description.

•Write procedures, protocols, reports, risk assessments applicable to the area

•Assist in procedure, protocol and report writing as necessary.

•Participate in the tracking and completion of CAPA’s as required

•Support on-going continuous improvement activities of the site’s Pharmaceutical Quality System.

Your profile

C. REQUIRED EDUCATION:

Bachelor’s Degree in Biology, Chemistry, Pharmaceutical or related field

D. QUALIFICATIONS/EXPERIENCE:

•Minimum 3-5 year experience in FDA regulated environment, preferably in a pharmaceutical manufacturing setting.

•1-3 years’ experience in quality systems, customer interactions, and internal audits

•Intermediate to advanced Microsoft computer experience.

•Prior supervisory/managerial experience a plus

E. SPECIFIC SKILLS:

•Communicate clearly and persuasively with people at all levels of the organization as well as customers.

•Problem solving ability, strong analytical skills and diplomacy required.

•Anticipate and prioritize multiple priorities and ability to switch direction quickly.

•Demonstrate customer service and efficiency focus.

•Ability to influence others toward desired outcomes to mitigate company risk, ensure employee commitment, and drive desired change. Must be comfortable dealing with and resolving conflict. Strong solutions focus and be comfortable working in an environment which demands strong deliverables along with the ability to identify problems and drive appropriate solutions.

•Experience with customer and regulatory audits.

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.

•Basic 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.

•Intermediate Microsoft Access skills as evidenced by the ability to open an existing database and table, print an existing table, move from record to record, copy and paste data; add, find and edit records; select a record, delete a record, sort data, create and apply filters, create a query, and print reports; as well as the ability to create a form, add form headers and footers, change page layouts, create reports from a table, and create mailing labels.

•Basic PowerPoint skills as evidenced by the ability to create and save a presentation, add titles, edit and delete slides, reordering slides, applying slide masters, checking spelling, and adding clip art.

•Basic Microsoft Project skills as evidenced by the ability to assign resources and their work schedules to tasks, effectively use the different views, reports, and drawing tools, resolve time and resource conflicts, sort and filter information effectively and work with subtasks in an outline form, link tasks effectively and work with time constraints.

•Basic Visio skills as evidenced by the ability to design and manage basic diagrams, workflows and flowcharts.

F. PHYSICAL REQUIREMENTS/ENVIRONMENT:

•Traditional office environment

•Sitting 80% of the day; walking 20% of the day.

•Lifting requirements are slight and related primarily to files.

•Finger dexterity required to operate computer keyboard.

•Hearing at a level to enable one to hear normal conversation.

•Visual requirements of having the ability to read the computer screen, documents.

•Frequently subjected to pressure due to time-sensitive demands

Compensation range

73,000.00 - 81,000.00 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.

Benefits

+ 401K Plan: Unither Matches up to 6% on Employee Contributions each pay period.

+ Retirement plan: Unither has a 4% Retirement Savings Plan contribution each year on prior year earnings.

+ Performance bonus: Hourly employees recive this pay out Quarterly and Salaried employees recieve this Annually.

+ 11 Paid Holidays per year

+ Health Insurance: Benefit Premiums Paid 100% by Unither for EE, Spouse or Domestic Partner, and Children.

+ Dental and Vision Insurance: Offered for Employee, Spouse or Domestic Partner, and children.

+ Health Savings Account (HSA): Quarterly Contributions made by Untiher in addition to Employee contributions.

+ Life insurance: 2X employees Annual salary paid by Unither. Supplemental Life Insurance offered for Employee, Spouse or Domestic Partner and Children.

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!