Position Summary: We are seeking a highly organized and detail-oriented Document Control Specialist to join our Quality team at Swiss American CDMO. This role acts as a quality ambassador for the company by supporting the effectiveness of our document management system to ensure compliance with customer requirements, external standards, and internal specifications. This role requires having excellent analytical and critical thinking abilities that aid in problem-solving.

Essential Duties and Responsibilities include the following:

• Ensure that Quality Assurance (QA) functions are in compliance with all required Current Good Manufacturing Practice (cGMP) regulations
• Assist in internal and external audits as necessary
• Maintain compliant electronic archive for quality/batch records (scanning, filing) as required
• Assist with biannual review of Standard Operating Procedure
• Assist in monitoring and maintaining the Quality Management System (QMS) with activities such as facilitating batch record review/release, as well as assisting in closure of Change Controls, SOP revisions, Non-Conformance and Corrective Action and Preventive Action (CAPA) investigations
• Communicate with different departments and members of leadership in regard to findings
• Maintain a high level of cGMP compliance and stay abreast of industry and regulatory compliance trends and requirements
• Ensure activities are performed in accordance with federal, state, and internal SOP guidelines
• Review and analyze appropriate test results for the release of bulk and final product
• Other duties as assigned

Skills and Qualifications:

• Minimum High School Diploma and 4 years in a Manufacturing environment, required
• Experience in Document Control, Batch Record review or relevant Quality/Compliance function, preferred
• Excellent time management skills to coordinate multiple projects and adhere to tight timelines
• Proficient with Microsoft office software
• Strong organizational skills with the ability to work with a high degree of accuracy
• Excellent customer service to internal and external users of documents
• Familiarity with Quality Management System or other regulated environment
• Knowledge and adherence to industry regulations and company standards
• Excellent interpersonal, verbal, and written communication skills
• Proven ability to take initiative and deliver results through effective problem-solving and critical thinking
• Experience scanning paper documents and managing digital file

Work Environment:

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. While performing the duties of this Job, the employee is regularly exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate.

Physical Demands:

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.

The employee must regularly lift and /or move up to 25 pounds, frequently lift and/or move up to 50 pounds. While performing the duties of this Job I the employee is regularly required to use hands to finger! handle or feel and reach with hands and arms. The employee is frequently required to stand, sit, and climb or balance. The employee is occasionally required to walk; stoop kneel, crouch, or crawl; talk or hear and taste or smell. The worker is required to have visual acuity to determine the accuracy, neatness, thoroughness of work assigned (i.e., custodial, food services, general labor1etc.}.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.