QC Supervisor - Finished Products

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:

Coordinates and schedules laboratory activities, support activities, and continuous improvement initiatives to meet established turnaround times and communicated priorities. Provides technical and basic supervision of identified staff and support operations within the group. Responsibilities include oversight of training, and scheduling of daily workflow while ensuring established methods are followed. Ensure testing meets internal SOP, compendial and regulatory requirements. Responsibilities will also include interaction with other managers, and personnel outside the department.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES:

Ensures laboratory conforms to quality, safety, and governmental standards.

Ensures laboratory equipment is calibrated and follows an equipment maintenance and calibration schedule as required.

Reviews laboratory work requests to identify priorities.

Coordinates work of lab personnel to meet internal and external customer delivery dates.

Reviews and approves laboratory data

Drafts, reviews, and approves internal procedures and protocols associated with test methods and commercial support activities.

Participates in and reviews laboratory investigations

Serves as QC Subject Matter Expert on development projects as needed.

Participates in audits and prepares PR/Audit documentation as appropriate.

Employee Development & Training

Provides supervision and direction to staff and coordinates workflow within the group, including distributing work, disseminating information, assigning staff to cover for absences, providing technical assistance, answering questions, and resolving problems.

Monitors team’s attendance.

Manages employee performance by clearly defining job responsibilities and standards of performance, providing clear, thorough, and timely feedback. Promptly addresses performance problems through corrective action.

Evaluates and appraises employees’ performance and follows-up with proper documentation.

Investigates and addresses employee complaints and follows up with Manager and HR as required.

Ensure self and staff keep up to date on technical knowledge and developments that impact roles.

Ensures an effective learning environment by coaching employees, orchestrating learning opportunities, and providing relevant, high-impact feedback.

Assists in interviewing and hiring subordinate staff.

Understands HR policies and practices and uses them to manage employees.

Conducts ongoing assessment of training and training needs, including maintaining the training management system for staff.

Process Improvements

Participates in the identification and implementation of continuous improvement initiatives to increase efficiency and capacity.

Evaluates effectiveness of SOPs, identifies changes that would enhance processes, and ensures that all change control documentation is implemented.

Ensures stakeholders are appropriately trained on the process and any process changes.

Implements initiatives to reduce cost or waste.

Your profile

EDUCATION & EXPERIENCE:

Associates degree required; Bachelor’s degree in related field is preferred.

Minimum of eight (8) years in an FDA regulated release or support laboratory with demonstrable command and understanding of bench-level methodologies.

Ability to analyze problems via scientific methods and draw data supported conclusions

Firm understanding of data evaluation tools, including intermediate level statistics.

Firm understanding of cGMPs and compendia (USP/EP)

Computer Skills:

Ability to read, communicate and legibly write in English, analyze and interpret scientific and regulatory documents.

Demonstrable comprehension of cGMP’s and associated regulatory/compliance programs.

Ability to identify potential issues before they impact manufacturing and packaging operations.

Demonstrable understanding of chemical analysis, including wet chemistry techniques and instrumentation including HPLC, GC, LCMS and titration.

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.

Advanced 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; 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; as well as create and protect forms, use graphics, outline and organize long documents, create cross references, captions and bookmarks; use master documents to manage long documents, and create and use document templates.

Advanced 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; as well as the ability to enter and edit complex formulas, filter lists, sort ranges, create and run macros, and use data analysis tools (pivot tables, scenarios, etc.)

Intermediate 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; as well as use and print notes, changing color schemes, changing fonts, bullets, slide backgrounds; adding a table, changing a slide layout, adding a chart, creating organizational charts, and search & replace.

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: Direct supervision responsibility, including performance assessments, of 1 – 15 employees.

INTERNAL / EXTERNAL CONTACTS:Requires contacts within the department or functional area on routine matters, and contacts with other departments. Occasionally contacts individuals outside the organization. Contacts are primarily for the purpose of supplying or seeking information.

PHYSICAL REQUIREMENTS/ENVIRONMENT:

Occasional travel required for seminars, conferences, and training.

Ability to successfully complete a visual acuity assessment is required.

Must demonstrate visual acuity, color recognition, finger dexterity.

The ability to read, write, and communicate in English.

Work responsibilities involve chemical and biological agents that have assigned biological and chemical hazards.

Sitting approximately 70% of day and standing approximately 30% of day.

Work responsibilities may involve repetitive use of the hands through keyboarding, simple grasping and fine manipulation.

Occasional lifting of up to 35 pounds.

Normal office environment and occasional controlled environment work that may require removal of jewelry and cosmetics.

Some weekend, holiday, and irregular hours.Hours are predominantly weekday, first shift, eight (8) hour days.

Compensation range

85,000.00 - 95,000.00 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!