QC Analyst I-BioAssay

Planet Pharma; Memphis (TN); On-site; USD 28,000 - 33,000; Full time

Job summary

Planet Pharma in Memphis, TN is seeking a QC Analyst II to perform cell-based immunological assays, maintain meticulous records, and support QA activities in a fast-paced biotech environment.

The role requires a biology degree, 1–2 years of lab experience, aseptic technique, and knowledge of cGMP. Strong communication and teamwork are essential as you contribute to study design, data analysis, and investigations.

Qualifications

• Bachelor's degree in biological sciences or related field required.
• 1–2 years of applicable experience in laboratory, biotech, cell therapy, or related industry or a combination of education and experience.
• Experience with aseptic technique and mammalian cell culture.
• Familiarity with cGMP as defined in 21 CFR 210 & 211.
• Strong written and verbal communication skills.
• Ability to work independently and as part of a team.

Responsibilities

• Execute cell-based immunological assays and operate related instrumentation.
• Document results and ensure data integrity per SOPs.
• Design studies, analyze data, and present results.
• Enter observations into trend databases and support documentation.
• Assist with maintaining QC department operations (logs, inventories, filing).
• Support investigations (OOS, CAPA) and quality improvements.
• Adhere to SOPs and GMP/GLP guidelines.

Skills

Cell-based immunology methods

Documentation skills

Data analysis

Communication skills

Independent work

Team collaboration

Education

Bachelor's degree in biological sciences

Tools

Cell culture

Aseptic technique

cGMP awareness

Laboratory instrumentation

Job description

BASIC SUMMARY:

QC Analyst II requires the utmost attention to detail, very strong organizational skills, computer proficiency, and a basic understanding of laboratory instrumentation. In addition, effective communication skills and the ability to function in a fast-paced, highly technical environment are essential for success.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Strong background and experience with cell-based immunological in vitro methods (e.g. MLR, cytotoxicity, HLA-restriction, CTLp, cell proliferation, etc.) and instrumentation.
• An understanding of cGMP/GLP regulations as well as excellent documentation skills in order to complete paperwork dealing in all aspects of Quality Control Reviews test results of other QC analysts for accuracy and precision and maintains efficient workflow of an required testing documentation ensuring timely submission relative to product release dates
• Study design, data/statistical analysis, reporting results in both written and oral format (presentation)
• Enters observations and results into the appropriate trending databases for periodic analysis and trending
• Previous experience working with aseptic techniques and culturing of mammalian cells and familiarity with cell culturing basics
• Assists the QC Team with maintaining proper overall operation of department (inventories, logs, documentation, filing, etc.)
• Assists with implementation of quality improvement initiatives for QC laboratory operations Participates in laboratory, OOS, CAPA, or other investigations, as required
• Adheres to Standard Operating Procedures (SOPs) and good documentation practices to ensure data integrity and traceability
• Perform all other related duties as assigned.

QUALIFICATIONS:

• Bachelors degree in the biological sciences or related field preferred
• Minimum 1-2 years of applicable experience in laboratory, biotech, cell therapy, or related industry or a combination of 1-2 years of education and related work experience required.
• Previous experience working with aseptic technique and culturing of mammalian cells
• Familiarity with cGMP as defined in 21CFR210 and 211.
• Detail-oriented with strong written and verbal communication skills
• Experience in cell-based assays and molecular biology-based assays
• Ability to work independently and as part of a team

Pay Range: 20-24/hr *based on experience