MSAT Support Tech

Job Summary :

The MSAT Support Tech will support Data Pack, Document Coordination, Sample Coordination and Training Coordination for the Swiftwater Manufacturing Science and Technology Platform. These responsibilities will be carried out across all MSAT platforms / Functions.

I. Data Pack Assembly

Data pack assembly is critical position in the execution of validation and development studies. The position will support the Validation Specialist / execution by obtaining and compiling data into a data pack in accordance with

• guideline.

Responsibilities : Creation of a data pack skeleton; Obtain / print execution of protocol execution copies and Work Instructions; Gather test data; Create labels; Obtain and copy batch records; Obtain and print calibration reports (Pro Cal); Obtain and print any required test results (Labware / LIMS); Obtain and download any required training records (iLearn); Organize all the information listed above into the data pack according to

II. Sample Coordination

The sample coordinator is a critical role in the execution of validation and development studies. Failure to comply with the protocol could create deviations and possibly invalidate the studies. Annual sample quantities range from 12,000 to 20,000 samples per year. Sample volumes are typically 15,000-16,000 per year. The sample coordinator must have a working knowledge of sample management and transportation cGMP practices. Responsibilities for a sample coordinator include :

Responsibilities

Assist with MSAT Sample Plan : Assist in determining total number of samples based on protocols or notebook study; Prepare UPID based on protocol or notebook study sample requirements; Print move tickets for samples; Assist with sample delivery confirmation; Track progress of sample testing in Labware / LIMS and provide results upon completion of testing; Maintain cross functional communication with QC testing labs and MSAT stakeholders.

III. Document Coordination

The document coordinator's responsibility is to update and maintain a document list associated for MSAT projects. The number of documents managed will vary according to project load and can range from 700 to 1,200 documents. The coordinator will compile document lists from individual project documentation list and publish weekly at a minimum.

Responsibilities

1. Maintain Project Documentation List

2. Forms Coordination / Creation (Qualipso)

a. Update cGMP forms (1-2) per week as required for any updated MSAT procedures

b. MSAT document Periodic Review

c. Review Record and System (R&S) periodic review report (monthly) for MSAT documents. Provide monthly update to MSAT Platform heads

3. Laboratory Notebook Management

a. Managed and control of laboratory notebooks

4. Issuing and managing logbooks (print, bind and track)

5. Review and edit formatting for MSAT documents in Qualipso

IV. Training Coordination

The training coordinator's responsibility is to onboard incoming associates and assist in ensuring employees are properly trained to execute their job responsibilities.

Responsibilities

Review and edit modules; assign proper training to onboarded employees based on job roles; track progress of training; run training reporting though iLearn; ensuring trainers are qualified.

Position Skill Set :

1. Ability and willingness to meet the expected completion date

2. Communication with the specialist / executor and Group Lead is essential if unanticipated delays occur

3. Ensure accuracy of data pack prior to review with Group Leader and / or Specialist

4. Software Proficiency

a. MS Office 365 (Word, Excel, PowerPoint); ii. Sharepoint iii. ProCal

b. iLearn

c. Working knowledge of cGMP systems

d. SAP, iShift

e. Labware or similar sample management systems ie. Qualipso- Documentation system

f. Opstrakker electronic logbooks / eBR

Qualifications :

1. HS Diploma, Associates, or bachelor's degree

2. Experience in the Pharmaceutical Industry; 1-3 years minimum