Hybrid Specialist, Document Control bei Sunstar Americas, Inc.

At Sunstar Americas, Inc., we firmly believe that our people are the foundation of our success. We foster a collaborative, innovative, and agile culture that ensures we deliver high-quality, innovative products to consumers and oral care professionals. Our team-oriented approach encourages creative thinking and nurtures a positive work environment and productive relationships. With dedication, hard work, and a shared vision, we can continue to make SAI a leader in our industry. 

Join us and become part of our global team, where together, we can achieve success and contribute to a better future.

Essential Job Functions: 

• Support all users of the eDMS in training, trouble-shooting, and resolution of any issues system upgrades and Data Integrity compliance.
• Ensure compliance with all requirements of document change control, control of records and training procedures as well as monitor performance, timeliness and progress of document changes and new documents.
• Issuance and maintenance of controlled documents in accordance with current cGMP requirements, policies and procedures.
• Manage disposition of QMS records, including archival, retrieval, offsite storage and destruction of records in accordance with policies and procedures.
• Support the Document Control and Training Specialist role as needed including but not limited to, performing administrative tasks in the QMS Learning Management System (LMS) as needed.
• Support the HR onboarding process as needed.
• Support Annual GMP Training as needed.

 Requirements:

• Attention to detail and ability to follow and reinforce procedures and system requirements, compliance expectations, management direction and customer / end user requests.
• Execute/remediate standard document formatting and MC requirements utilizing Microsoft Word, Excel and Adobe Acrobat PDF within the web-based application.
• Understand and execute best practice on good documentation practices (GDP), change management requirements, and Quality Management Systems for regulated industry requirements of medical device and pharmaceutical manufacturers.
• Help identify, monitor and implement changes to processes for increased efficiency, end user understanding, compliance initiatives and continuous improvements.
• Strong interpersonal skills to interface and work directly with cross functional teams.
• Strong Microsoft Office skills (especially Word, Excel) as well as Adobe Acrobat.
• Good proofreading, editing, and technical writing skills
• Strong problem analysis and resolution skills and ability to work independently.
• Excellent interpersonal and organizational skills
• Awareness of CGxP, GMP, GDP and/or ISO standards desired (specifically QSR, CFR 820, 211, Part 11 and ISO13485)

Education

•  Bachelor’s Degree, Business Information Systems or equivalent degree

Knowledge/Experience

•  At least three to five years previous experience in Biologics, Pharmaceuticals, and/or Medical Device regulated company, in a Quality and change management discipline.
• Previous experience in Training, Change Control, electronic document management systems, Quality Assurance, or regulated organizations is required
• Previous experience in documentation requirements, Data Integrity requirements and database management.
• Previous experience with Learning Management System(s), document change control, record retention, training execution, training effectiveness measures and training and change control programs metrics.
• Experience with eDMS document control software is preferred.

What Makes Sunstar Special is:

• A business focused on health and wellness of people around the world
• High Quality Products
• Beautiful state-of-the-art facility
• Diversity and Inclusion
• Corporate Social Responsibility Program and partnership with charitable organization
• Strong value placed on company culture
• Excellent, comprehensive insurance coverage that includes Medical, Vision, and Dental benefits. 
• Opportunities for career growth and advancement
• Employee discount on Sunstar products
• 401K retirement plan with employer match (Pretax and Roth options)
• 401K profit sharing contribution based on company performance.
• Paid holidays and generous paid time off. Pet, Legal and Identity Theft Insurance Plans
• Competitive bonus
• On-site café
• On Site Fitness Center
• Corporate Perks Discount Program (Auto, Retail, Electronics, Entertainment, Computers, Personal Vacations, Cell Phones, Movie Tickets, Eating Out and Much More)
• Holiday Lunches
• Beautifully maintained walking trails
• Hybrid Schedule (certain departments)
• Numerous employee appreciation events throughout the year.
• Recognition and Rewards Programs
• Anniversary, Birthday and New Hire Announcements

 If you’d enjoy a career helping others attain overall health through oral health, consider joining the Sunstar Americas, Inc. team.

The employer is subject to certain governmental record keeping and reporting requirements for the administration of civil rights laws and regulations. In order to comply with these laws, the employer invites employees to voluntarily self-identify their gender, and race or ethnicity. Completion of this data is voluntary and will not affect your opportunity for employment or terms or conditions of employment. Information collected will be used for EEO-1 reporting purposes only and will be kept separate from all other personnel records, only accessed by Authorized Users. Information collected will be kept confidential and will only be used in accordance with the provisions of applicable laws, including those that require the information to be summarized and reported to the federal government. When reported, data will not identify any specific individual. 

The pay range for this position of Document Control Specialist is $65,821- $92,150. However, base pay offered may vary depending on skills, experience, job-related knowledge and location. This position is also eligible for an annual bonus as part of total compensation.