Website Mindlance
Mindlance
Company : Mindlance
Job Description:
Job Description Job Summary
As a Quality Control Analyst, you will be responsible for testing of raw materials and finished products in our Quality Control laboratory.
PRIMARY RESPONSIBILITIES
- Conducts routine and non-routine chemistry and microbiological analysis of raw materials, in-process formulations, and final products to established specifications.
- Utilized and operates laboratory equipment and instruments according to laboratory work instruction or laboratory procedures such as pH, conductivity, UV, KF, FTIR and titrations.
- Ability to understand and follow Quality Control test methods or compendia methods (USP, EP, BP, JP or Client) and EXCIPACT standard.
- Calculates and generates data for compliance to specifications and reports results.
- Performs technical review of lab data forms such as water, environmental monitoring and direct measure analysis.
- Calibrates and maintains lab equipment.
- Enters final results and raw data for tested materials or products in LIMS (Laboratory Information Management System) as needed.
- May perform investigative analysis to support investigations, complaints or instrument troubleshooting.
- Performs Environmental Monitoring duties, which requires gowning into cleanroom and collection of air and surface samples while in the cleanrooms.
- Reviews for discrepancies in data, manufacture COA, COC, and performs data verification in accordance with company procedures.
- Applies appropriate disposition labels to materials (accepted, rejected, etc.)
- Handles hazardous materials using all appropriate or mandatory safety PPE and safety equipment.
- Completes documentation in a legible manner and reviews for accuracy
- Performs sampling and testing for USP Purified water and Water for Injection
- Author, review or update lab procedures and Lab instruments Work Instructions.
- Perform microbiological test such as: bioburden, endotoxin, Dnase, Rnase, Protease, and Phosphatase using proper aseptic techniques .
- Prepare and properly dispose of microbial media
QUALIFICATIONS
- Bachelors degree in a science discipline with knowledge and experience in one of the following areas: Chemistry, Biology, or Microbiology
- 1-3 years of laboratory experience in related field
- Wet chemistry and microbial testing experience preferred (ex. Acid/Base Titrations, water content, Bioburden, Endotoxin)
KNOWLEDGE SKILLS AND ABILITIES
- Applied working knowledge of various laboratory instrumentation
- Ability to work collaboratively in a diverse team environment with people at all levels in the organization
- Proficiency in Microsoft Word, Power Point, Excel and Access
- Strong problem solving and analytical skills
- Ability to communicate effectively, both verbally and in writing
ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT
- Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level.
- At times, may be exposed to a variety of different chemicals including flammables, corrosives, oxidizers, and others.
- Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.
- A frequent volume of work and deadlines impose strain on routine basis.
- Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting, or carrying objects that typically weigh less than 10 lbs.
Skills/Experience:
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EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.