• Prepare technical Quality documents including but not limited to batch records for new products and products requiring changes through creation, review, and approval to ensure compliance prior to final release for production.
• Understand and comply with all standard operating procedures applying to the change control process.
• Contribute to ongoing process improvements with focus on document accuracy, efficiency, and regulatory risk mitigation.
• Collaborate cross-functionally with Product Managers, Research & Development (R&D), Procurement, Quality Control (QC), Regulatory, and others to gather information and provide feedback related to change control product documentation.
• Create and update relevant information within electronic Quality Management Systems (QMS).
• Manage workflow of documents and communicate with colleagues to track documents to release.
• Monitor production schedule and prioritize workload based on production scheduling changes.
• Understand and follow Good Documentation Practices (GDP) requirements with a focus on Change Control.
• Audit new or changed documents for accuracy.
• Provide backup support as directed, including Document Control and QMS activities.

Education & Experience:

• High school diploma or equivalent.
• 3 years’ professional Quality document control, change control, or engineering documentation experience, or commensurate combination of higher education and work experience.

Knowledge, Skills, & Abilities (KSAs):

• Ability to interpret and apply Good Manufacturing Practice (GMP) regulations.

• Strong technical writing skills and the ability to create technical documentation.
• Strong organizational planning and written communication skills.

• Proficient in Microsoft Office, including Excel and Word.
• Ability to calculate figures and amounts such as, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of an organization.
• Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.

• Degree in business, science, engineering, or related field.
• Prior manufacturing, GMP, consumer packaged goods, pharmaceutical and/or nutraceutical industry experience.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee is occasionally required to walk, sit, reach with hands and arms, climb or balance, taste and smell, lift or carry items up to 25 pounds, and push or pull items up to 10 pounds. The employee must frequently stand and use hands to finger, handle, or fell; and constantly required to talk and hear. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually low, however since this position is located within manufacturing there may be occasions where increased levels of noise and exposure to particles related to the nature of work. The position is frequently exposed to toxic or caustic chemicals.

All employees are expected to carry out their functions in a healthy and safe manner, to always encourage and support safe work practices, and to report and/or rectify any unsafe conditions that may come to their attention immediately. All SCN BestCo employees must wear PPE as required based on their job duties.