Summary: Under close supervision, responsible for performing basic stability operations such as study initiation, samples pulling, data entry and trending analysis.Essential Job Functions:
- Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
- Loads and unloads stability samples in the GMP qualified chambers.
- Monitors stability chamber conditions (temperature and relative humidity) on daily basis and review/audit the corresponding
logbooks for pages completionInitiation of stability studies following the approved protocols, stability samples labeling and creation of electronic files in ScienTek software.
Scheduling of stability samples to be submitted to the laboratory for testing using the ScienTek software.
Laboratory data entry in ScienTek software electronic files.
Generation of FDA recommended stability tables/reports for submission to Regulatory Agencies.
Perform statistical trending analysis of data using the tool package in ScienTek software.
Alert the Laboratory Management of any trending identified that can compromise the expiration date of the drug product.
Keep stability chambers clean and organized.
Request issuance of new stability logbooks to R&D Quality Assurance Department.
Works in team oriented environment. Assists scientist principal and scientist senior on stability data and samples retrieval
Performs related duties as assigned.
Required Knowledge and Skills:
- Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
- Business English usage, spelling, grammar and punctuation.
- SOP's, cGMP's, equipment procedures and safety practices.
- Proper English grammar and punctuation.
- Standard Operating Procedures for stability and laboratory operations.
- GMP compliance in a regulated work environment.
- Basic math skills.
- Record keeping skills.
- Different units of measurement (i.e., milligrams, grams and kilograms).
- Current Company policies and practices, including safety rules and regulations.Skill in:
- Communicating clearly and concisely, both orally and in writing.
- Ability to read, write and understand documentation in English.
- Establish and maintaining cooperative working relationships with others.
- Providing excellent customers service with both internal and external customers.
- Ability to use material handling equipment.
- Working independently as well as in a team environment.
Minimum Qualifications: High School diploma or equivalent, and minimum of nine (9) or more years of experience, preferably in pharmaceuticals, cosmetics or food industry; or an equivalent combination of education and experience.Physical Requirements and Working Conditions: Incumbents in this class are subject to extended periods of sitting, standing, walking, vision to monitor, occasional lifting of materials weighing up to 10-20 pounds. Work is mainly performed in an office environment with access to laboratory and warehouse where stability chambers are located.