Quicksilver Scientific, Inc
  • Lafayette, CO, USA
  • Full Time

Quicksilver is a pioneer in the natural health industry. Our mission is to deliver on the promise of natural medicine, delivering products that help individuals achieve mind and body health through nature inspired innovation. Our growth is fueled by individuals who share our passion. Currently, we are excited to announce an opening for a Quality Assurance (QA) Document Specialist in our Lafayette, CO office.

The Quality Assurance (QA) Document Specialist will be responsible for the set up and maintenance of our records/data management system to capture all records control requirements, including maintenance of files, quality assurance, information conversions, and systems automation, as applicable. The person will be responsible for all activities of Document Control involving quality assurance and compliance with applicable regulatory requirements; conducts audits and reviews/analyzes data and documentation and supports the overall Quality Assurance function through various QA tasks.

 

Core Responsibilities include:

  • Responsible for applying requirements to the design and execution of the Document Control function.
  • Manage the Document Control system including, but not limited to numbering system, templates for Standard Operating Procedures (SOPs), forms, logs, specifications, test methods, master manufacturing records, batch production records, master packaging records and batch packaging documents.
  • Responsible for training and enforcing the safe storage and back-up of cGMP documents and others as required.
  • Document revision control including update of any satellite locations, and assessment of revision impact.
  • Review of master label changes, proof approval, file update, communication to interested parties, and coordination with outside printers as needed.
  • Issuance of batch records, coordinating with QA manufacturing-support team and Production for timely execution.
  • Tracking, Review, Approval, and Logging (including electronic back-up) of Document Change Requests.
  • Technical writing of new documents, updates to raw material, in-process, and finished product specifications, analytical methods, stability report management, and working with all departments for approvals and implementation.
  • Provide back-up support for QA Manufacturing support team as needed.
  • Provide coaching, training and interaction with new and/or junior QA staff and other cGMP employees as assigned, may include the development of workflow diagrams or Work Aids (visual management).
  • Other QA tasks as required.

 

Qualifications:

Qualified candidates must have an Associate or Bachelor's degree in comparable field (varies when combined with industry experience) and a minimum of 2 years of experience in a similar role. Must have an intermediate skill level in MS Office Suite. Must be proficient in SharePoint.

 

Ideal Candidates have the following traits:

  • Intermediate skill level in SharePoint
  • cGMP experience in pharmaceutical, medical device, or dietary supplement industry
  • Experience working within a Quality Management Software (QMS) such as TrackWise or MasterControl.

 

Quicksilver offers a competitive benefits package including:

Employer paid Medical, Dental, Vision, and Life insurance; including Short-term and Long-term Disability.

401K with company matching.

Paid vacation and sick time.

Paid company holidays.

Fitness Center membership.

Generous employee discount program on all QS products.

 

Quicksilver Scientific is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

 

Quicksilver Scientific, Inc
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