Lab Technician/ QC chemist/ Downstream Purification Technician/ Analytical Chemist
Not Disclosed•TemporaryOn-site
location_onExecutive Drive, Drexel Gardens, Indianapolis, Marion County, Indiana, 46241, United States
About the Role
This 12-month onsite assignment at our Indianapolis facility serves as a critical support function for the quality control laboratory. The QC Chemist (Raw Material) is responsible for ensuring the integrity of all technical aspects related to quality control testing readiness. From managing reagents and materials to overseeing equipment preparation and daily maintenance, this role ensures the laboratory operates in full compliance with GMP regulations, procedures, and product specifications.
In this position, you will be the first line of defense in maintaining product quality. Your day-to-day involves executing finished product testing, environmental monitoring, and sterility QC testing, followed by the precise reporting of results. You will play a key role in the quality ecosystem by managing non-conformances and deviations, supporting investigations into Out-of-Specification (OOS) or Out-of-Trend (OOT) events, and driving CAPA follow-ups. Additionally, you will assist in qualification and validation activities while ensuring all analytical batch records and documentation adhere to strict Good Documentation Practices.
Hiring Process
Interested candidates should apply directly through the provided portal. The selection process typically involves a review of qualifications followed by an interview to assess technical competency in cGMP environments and aseptic techniques.
Equal Opportunity & Culture
SPECTRAFORCE is committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. We are an equal opportunity employer dedicated to fostering a diverse and inclusive environment.
For detailed information regarding benefits, equal opportunity employment policies, and location-specific applicant notices, please refer to the official application resources.
Work location
Work model: On-site
Executive Drive, Drexel Gardens, Indianapolis, Marion County, Indiana, 46241, United States
Indianapolis, Indiana
Key Responsibilities
- check_circlePrepare analytical batch records and maintain documentation in compliance with GMP
- check_circleSupport internal and external audits and inspections as required
- check_circleInterpret analytical data and convert findings into technical documentation
- check_circleManage non-conformance escalations and quality incidents per procedures
- check_circleParticipate in equipment qualification and validation activities
- check_circleConduct finished product, environmental monitoring, and sterility QC testing
- check_circleSupport deviation, OOS, and CAPA investigations and change control management
Requirements
- verifiedBachelors degree in Chemistry or Microbiology
- verified2-3 years experience in cGMP or aseptic environment
- verifiedHPLC knowledge
- verifiedCompendia experience (USP, EP, BP, JP, CP)
- verifiedKnowledge of cGMP regulations and FDA guidance
- verifiedMicrobiology method verification and routine testing practices
- verifiedAseptic techniques and principles
Nice to Have
Practical experience with Microbiology method verification and routine testing practices, EM Monitoring and basic knowledge of method/equipment validation principle and methodologies.
Similar Job Opportunities
Skills, education and keywords
Skills: GMP, Usp, Ep, BP, JP, CP, CGM P, Aseptic Techniques, Aseptic Principles, Microbiology.
Education: Bachelor's degree required in relevant Scientific discipline (e.g Chemistry, Microbiology).
Frequently asked questions about Lab Technician/ QC chemist/ Downstream Purification Technician/ Analytical Chemist at SPECTRAFORCE
What does a Lab Technician/ QC chemist/ Downstream Purification Technician/ Analytical Chemist at SPECTRAFORCE do?expand_more
Day-to-day, the Lab Technician/ QC chemist/ Downstream Purification Technician/ Analytical Chemist at SPECTRAFORCE will prepare analytical batch records and maintain documentation in compliance with gmp; support internal and external audits and inspections as required; interpret analytical data and convert findings into technical documentation; and manage non-conformance escalations and quality incidents per procedures.
What are the requirements for this Lab Technician/ QC chemist/ Downstream Purification Technician/ Analytical Chemist role?expand_more
To qualify for the Lab Technician/ QC chemist/ Downstream Purification Technician/ Analytical Chemist at SPECTRAFORCE position, applicants should have: Bachelors degree in Chemistry or Microbiology; 2-3 years experience in cGMP or aseptic environment; HPLC knowledge; Compendia experience (USP, EP, BP, JP, CP); Knowledge of cGMP regulations and FDA guidance; and Microbiology method verification and routine testing practices.
Where is the Lab Technician/ QC chemist/ Downstream Purification Technician/ Analytical Chemist role at SPECTRAFORCE located?expand_more
Lab Technician/ QC chemist/ Downstream Purification Technician/ Analytical Chemist at SPECTRAFORCE is based in Executive Drive, Drexel Gardens, Indianapolis, Marion County, Indiana, 46241, United States. This is a on-site role.
Is this Lab Technician/ QC chemist/ Downstream Purification Technician/ Analytical Chemist job remote, hybrid, or on-site?expand_more
SPECTRAFORCE has listed this Lab Technician/ QC chemist/ Downstream Purification Technician/ Analytical Chemist role as on-site.
How much experience is required for this Lab Technician/ QC chemist/ Downstream Purification Technician/ Analytical Chemist role?expand_more
Lab Technician/ QC chemist/ Downstream Purification Technician/ Analytical Chemist at SPECTRAFORCE typically requires 2–3 years of relevant experience at the mid level level.
What skills do you need for the Lab Technician/ QC chemist/ Downstream Purification Technician/ Analytical Chemist role at SPECTRAFORCE?expand_more
Key skills for Lab Technician/ QC chemist/ Downstream Purification Technician/ Analytical Chemist at SPECTRAFORCE include GMP; Usp; Ep; BP; JP; CP; CGM P; and Aseptic Techniques.
What education is required for Lab Technician/ QC chemist/ Downstream Purification Technician/ Analytical Chemist at SPECTRAFORCE?expand_more
Educational requirements for this role: Bachelor's degree required in relevant Scientific discipline (e.g Chemistry, Microbiology).
What category does the Lab Technician/ QC chemist/ Downstream Purification Technician/ Analytical Chemist role belong to?expand_more
Lab Technician/ QC chemist/ Downstream Purification Technician/ Analytical Chemist at SPECTRAFORCE is part of the scientific & qa job category on Recrutus.