Job Location : Rochester,NY, USA
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 -this position is a split shift, flexible hours 11am - 7:30pm or 12pm - 8:30pm
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.
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
22.00 - 27.00 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!