Job Description

How will you make an impact?

Manage Document Control for assigned area. Process work orders, line templates, line set-up sheets, work instructions, single point lessons forms, training documents, and standard operating procedures in Document Management Systems. Process Trackwise records as needed. Support manufacturing and packaging operations with GMP related administrative tasks such as 1)Inventory management and SAP data entry for batch operations, 2)Requesting, Reviewing, and Returning Equipment Logbooks and 3)Transferring of Release, Stability, Retain and special testing samples to the Labs using LIMS. Typical hours for this role would be Monday - Friday, 7:30am 4pm.

What will you do?

* Initiate Site Change Controls.
* Develop, update, and perform document administration for work orders, line templates, line set-up sheets, work instructions, single point lessons forms, training documents and standard operating procedures for assigned area.
* Manage Document Control (Forms, Logbooks, SOPs and SPLs) for assigned area.
* Enter SAP data and manage inventory for or batch operations.
* Transfer samples to Stability/Retains and transfers sample to Labs using LIMS.
* Train others within department.
* Perform other duties as assigned.

How will you get here?

Education

High school diploma or GED is minimally required.

Experience

Four years of relevant experience is preferred. Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, Abilities

* Outstanding attention to detail and organizational skills. Self-starter, mature, independent and dependable.
* Ability to work in a fast paced environment under pressure, able to multi-task and is results-oriented.
* Effective time management and prioritization skills. Requires discretion, great listening skills and independent judgment.
* Highly effective verbal and written communication skills. Familiarity with a variety of concepts, practices and procedures.

Physical Requirements

* Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.