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QA Operations Documentation 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 Customer and Operations Quality Manager,

A. JOB SUMMARY:

The QA Operations Documentation Specialist position provides documentation support aligned with commercial and development production. This position interacts with cross functional departments throughout the site to ensure all cGMP documentation is ready in advance of the schedule.

The QA Operations Documentation Specialist is responsible for ensuring all necessary instructions and associated documentation is printed, verified and provided to the operations team. This position is also responsible for ensuring completed batch documentation is scanned into the system and sent to the customers.

Other responsibilities of this role may include assisting with documentation archive, filing, and label issuance.

B. DUTIES / RESPONSIBILITIES:

•Issuance of working batch cards for manufacturing, packaging, cleaning and all associated forms

•Entering the information into TabFusion

•Scanning completed batch records

•Communicating with various customers and sending the completed scans to them for review

•File/Assist with filling of all documentation housed in the Documentation Room

•Assisting with maintaining tracking system for records that have been requested, checked-out, and returned as needed

•Review and approve the manufacturing date and the expiry date in Shelly system (WMS)

•Responsible for the retained room, and periodical check of the products

•Responsible for the Right First Time KPIs completion before batch cards archive

•Responsible for batch card archive

Your profile

C. REQUIRED EDUCATION:

AAS degree or BS degree in Life Sciences, Communications, Business Administration, Technical Writing, or related field is preferred.

D. QUALIFICATIONS/EXPERIENCE:

•1-3 years’ experience working in a production, pharmaceutical or regulated environment.

•Computer proficiency with working knowledge of EnnovDoc and/or TrackWise preferred.

•Ability to work autonomously using established procedures, seeking guidance where needed.

•Self-motivated and demonstrated ability to learn and work in a fast-paces environment where multiple concurrent projects must be completed in a timely manner.

•Experience in audits and regulatory inspections a plus

E. SPECIFIC SKILLS:

•Professional communication skills with customers, leadership, and peers – communication via telephone, written form, e-mail, and in person are all required.

•Attention to detail: Observing and interpreting document system data and patterns

•Compiling, coding, categorizing, and other types of processing documentation

•Teaching and training others

•Excellent organizational skills

•Innovation and thinking creatively to solve problems

•Time management

•Inventory management

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

45,000.00 - 50,000.00 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!