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Job Details



Laboratory Execution System Administrator  Marietta, PA  Posted: 9/14/2022
Job Description

Job ID#:

7314


Alphanumeric is hiring a Laboratory Execution System Support Analyst to work in Marietta, PA 

Important Skills/Experience:
* experience with LabWare software
* SAP - transaction creation
* Excel mastery
* Customer service and ability to interact with lab scientists (value team input and work together)

Manage Lab Support systems and processes for QC, including: Master Data, Monograph Creation, Stability and Laboratory Execution System Administrator. Execute non-routine, non-testing tasks within QC, including change controls, material on-boarding, and SAP training. Local Business Owner for SAP QC Master Data and LES.

Duration: 1 year, opportunity for FTE
Hybrid schedule - 50/50
(implementation of electronic lab systems so there will be some onsite work but a lot can be handled remotely)
Work Schedule
Monday-Friday day shift 8 hour day within 7am-5pm timeframe


Responsibilities
* Drive a strong safety culture within QC and the site. Adhere to established EHS policies and procedures.
* Owns QC, LES, Master Data, and execution of tasks.
* Local Business Owner for QC SAP Modules. Maintain SAP processes and perform training to grant QC SAP roles to users. Generate master data related to QC (monographs, specifications, inspection plans, etc.). Ensure that master data is complete and accurate. Serve as SAP Module/LES SME for method implementation and improvement.
* Support business during method creation and revisions within LES and SAP - e.g. Data Collection, Prototype, DCMA, BCO and Hypercare
* Collaborate with QC teams, global team, support teams, and other sites to ensure compliant processes. Benchmark with sites to ensure processes are optimized and in alignment within the network.
* Work closely with biochemistry and microbiology laboratories to optimize all LES methods.

This position requires that all workers be fully vaccinated against COVID-19 and proof of vaccination will be required. Considerations will be made for those seeking Medical Exemption under ADA or Religious exemption under Title VII

 
Job Requirements

 

Knowledge/ Education / Previous Experience Required

Education
Minimum Level of Education: B.S or B.A in Microbiology, Biochemistry, or a related scientific discipline. Degree in other discipline if sufficient technical depth has been achieved from professional experience.
Area of Specialization: Microbiology, Biochemistry, or a related scientific Degree in other discipline if sufficient technical depth has been achieved from professional experience.

Preferred Level of Education: BS
Area of Specialization: Microbiology, Biochemistry, or a related scientific Degree in other discipline if sufficient technical depth has been achieved from professional experience.

Job-Related Experience
* Minimum of 3 years experience in cGMP-regulated environment.
* Previous experience with LIMs, SAP, and/or LES is preferred.

Other Job-Related Skills/Background
* Working knowledge of pharmaceutical facilities, equipment and systems. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities.
* Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance.
* The ability to communicate both verbally and in writing with all levels both inside and outside of the organization. The ability to clearly write technical documentation as necessitated by regulatory agencies and internal policy.
* Ability to establish and maintain working relationships with staff and the ability to analyze data and implement changes.
* Must be able to address complex problems associated with assessing deviations, determination of root cause, and implementation of change and improvement to validated and/or FDA approved production systems.
* Must have an aptitude for facilitating a team environment and working independently toward the goal of completing product investigations.
* Participate in cross-functional deviations as needed.
* Must have strong technical writing skills.




 

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