Associate - LIMS
Key Responsibilities:
- Provide Tier 1 support to the laboratory, answering questions and providing technical support to management and laboratory personnel.
- Assist with preparing LIMS stability studies for incoming new product set downs (release and process validation samples).
- Assist with creation of LIMS Product Specifications, Item Codes, and related LIMS components for new products.
- Assist with revising LIMS Product Specifications, Item Codes, and related LIMS components for specification changes.
- Apply LIMS Product Specification changes to existing samples in the R&D Chemistry laboratory.
- Assist with Stability Management duties as assigned.
- Perform other duties as assigned.
Minimum Qualifications:
- Bachelorβs degree (or equivalent) and 0β2 years of experience. Labware LIMS and/or pharma experience preferred (or an equivalent combination of education/experience).
- Knowledge of GXPs, 21 CFR, and health authority requirements; ability to follow government regulations and company/department policies. Familiarity with product testing methods/specifications is a plus.
- Strong communication, technical writing/documentation, comprehension, time management, and computer skills (Microsoft Office Suite). Accurate, detail-oriented; able to multi-task; strong organizational and deductive reasoning.
- Ability to read/interprete business documents; write routine reports and correspondence.
- Ability to perform computations (percentages, ratios, rates) and interpret graphs/data.
- Ability to solve routine problems using standardized solutions and follow prescribed procedures.
- English proficiency required.
Benefits:
- Competitive salaries and benefits.
- Inclusive environment.