At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

Are you interested in joining our team?

The Senior Document Control Coordinator is accountable for driving results in a fast-paced environment by providing support related to documentation system requirements. The ideal candidate will maintain documentation and files to assure they are accurate, up-to-date, and available to appropriate personnel as necessary. The position maintains systems providing change control for master documents and generates requested documents and reports when requested.

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

• Audits document files, both electronic and paper, to ensure compliance with external and internal quality assurance requirements.
• Maintains accurate and up-to-date documentation and files.
• Applies basic and some advanced skills in procedures, techniques, tools, materials, and/or equipment appropriate for area of specialization.
• Resolves moderately complex questions and refers more complex questions to higher levels.
• Assists in training other support personnel on various job duties.
• Supports new hire orientation and facilities training on the document control system, MasterControl.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

• High school diploma or equivalent.
• Minimum 5 years of QMS / eQMS experience required. MasterControl experience highly preferred.
• Other combinations of education and experience may be considered as equivalent.

• General working knowledge of word processing, reports, and presentation creation.
• Proficient in Microsoft Office programs.
• Good verbal and written communication skills.
• Works well in team setting.
• Excellent attention to detail and sense of urgency.

• Up to 5% travel required.

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. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit.

The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually quiet.