QA Operations Documentation Specialist

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 280 employees.

Your role

Reporting to the Quality Assurance Manager ,

Please note - we are looking to hire 2 candidates for this role, one for A-Shift and one for B-Shift.

The QAOperations Documentation Specialist position provides documentation supportaligned with commercial and development production.

This position interacts with cross functionaldepartments throughout the site to ensure all cGMP documentation is ready inadvance of the schedule.

The QAOperations Documentation Specialist is responsible for ensuring all necessaryinstructions and associated documentation is printed, verified and provided tothe operations team.

This position isalso responsible for ensuring completed batch documentation is scanned into thesystem and sent to the customers.

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

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 retention room, and periodical check of the products

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

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

Basic Outlook, Immediate Microsoft Word, Basic Excel, Intermediate Microsoft Access, Basic PowerPoint, Basic Microsoft Project

Basic Visio

Your profile

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

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

Compensation range

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!