Quality Control Chemist I

Planet Pharma; San Antonio (TX); On-site; USD 34,000 - 41,000; Full time

Job summary

Planet Pharma in San Antonio, TX is seeking a quality control professional to perform testing of raw materials, intermediates, and final products using cell-based bioassays, ELISA, qPCR and flow cytometry. You will maintain lab equipment, review data, and help generate CoAs for release, while ensuring adherence to GMP/SOPs.

The role involves assisting with investigations of out-of-spec results, supporting root cause analyses, and contributing to continuous improvement initiatives.

Qualifications

• Bachelor's or AA with QC biotech experience; higher degree preferred.
• GMP/SOP proficiency required in a quality control lab.
• Experience with analytical methods such as Flow Cytometry, ELISA, PCR.

Responsibilities

• Test raw materials, intermediates and final products using validated methods.
• Maintain lab equipment and collaborate with internal/external resources.
• Review records for in-process testing and product release, generate CoAs.
• Assist with SOPs, qualification/validation protocols and reports.
• Investigate OOS results and determine root causes for deviations.
• Provide updates at daily/weekly meetings and ensure GMP compliance.
• Review proposed changes to systems and communicate with regulators as needed.
• Collect metrics for continuous improvement and perform other duties.

Skills

GMP knowledge

Quality control

Laboratory testing

Data analysis

Communication skills

Independence

Analytical techniques

Education

Bachelor's degree or above

AA degree with 2+ years biotech QC

High School + 3+ years biotech QC

Tools

MS Word

MS Excel

PowerPoint

Flow Cytometry

Job description

Responsibilities

• Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.


• Work with internal and external resources to maintain lab in an optimal state.


• Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Supply information to support generation of CoAs for product release.


• Maintains laboratory instruments for calibration and routine maintenance


• Author or revise SOPs, qualification/validation protocols and reports.


• Asist with lab investigations regarding out of specifications (OOS) results. Participate in determination of root cause for deviations related to analytical procedures.


• Provide updates at daily and weekly meetings.


• Monitor the GMP systems currently in place to ensure compliance with documented policies.


• Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.


• Gather metric information for use in continuous improvement of areas of responsibility.


• Perform other duties as required.

Basic Qualifications

• Bachelors Degree OR


• AA Degree and 2+ years experience in biotechnology or related field and Quality Control experience OR


• High School Degree and 3+ years experience in biotechnology or related field and Quality Control experience

Preferred Qualifications

• Strong knowledge of GMP, SOPs and quality control processes.


• Identifying, writing, evaluating, and closing OOSs and investigations.


• Proficient in MS Word, Excel, Power Point and other applications.


• Strong written and verbal communication skills.


• Ability to communicate and work independently with scientific/technical personnel.


• Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.


• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).


• Preferred: Experience in the biotech and/or pharmaceutical industry.

Pay ranges between 25-30/hr