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Overnight Biotech Quality Control Jobs in Indiana

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Overnight Biotech Quality Control information

What is an overnight biotech quality control?

Overnight Biotech Quality Control jobs involve performing laboratory tests and inspections on biotechnology products during nighttime or overnight shifts. These professionals ensure that products such as pharmaceuticals, biologics, or laboratory samples meet quality and safety standards before they reach the market. Responsibilities often include running assays, documenting results, maintaining equipment, and following strict protocols and Good Manufacturing Practices (GMP). Working overnight helps maintain round-the-clock quality assurance in fast-paced biotech environments. Candidates typically need a background in biology, chemistry, or related fields and attention to detail.

What are the key skills and qualifications needed to thrive as an overnight biotech quality control professional?

To thrive as an Overnight Biotech Quality Control professional, you need a strong background in biology or chemistry, attention to detail, and familiarity with quality assurance practices, often supported by a relevant bachelor's degree. Proficiency in laboratory equipment, data analysis software, and compliance with regulatory standards like GMP or ISO is typically required. Strong problem-solving skills, reliability, and effective communication are important soft skills for this role. These skills are crucial to ensure consistent product quality, regulatory compliance, and effective issue resolution during overnight operations.

What are some common challenges faced by overnight biotech quality control professionals, and how can they be managed?

Overnight Biotech Quality Control professionals often encounter challenges such as working with limited onsite support, maintaining focus during late hours, and responding quickly to unexpected results or equipment issues. Effective communication with day-shift teams and thorough documentation are essential to ensure continuity and avoid errors. Establishing a consistent routine, prioritizing tasks, and utilizing available digital resources can help manage the unique demands of this role and ensure the accuracy and reliability of quality control results.

What is the difference between Overnight Biotech Quality Control vs Microbiologist?

AspectOvernight Biotech Quality ControlMicrobiologist
CredentialsBachelor's in biology, microbiology, or related field; GMP trainingBachelor's or higher in microbiology, biology, or related field; lab certifications
Work EnvironmentLaboratory setting, often overnight shifts, regulated biotech facilitiesLaboratory, research, or clinical settings; may include overnight or day shifts
Industry UsageBiotech, pharmaceutical manufacturing, quality assuranceHealthcare, research institutions, biotech, pharmaceuticals

Overnight Biotech Quality Control specialists focus on testing and ensuring product quality in biotech manufacturing, often working overnight shifts. Microbiologists conduct research, analyze microorganisms, and may work in various settings, including clinical labs. While both roles require microbiology knowledge and lab skills, Quality Control roles emphasize compliance and product safety in biotech environments, whereas Microbiologists may have broader research responsibilities.

What are the most commonly searched types of Biotech Quality Control jobs in Indiana?

The most popular types of Biotech Quality Control jobs in Indiana are:

What are popular job titles related to Overnight Biotech Quality Control jobs in Indiana?

For Overnight Biotech Quality Control jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Overnight Biotech Quality Control jobs in Indiana look for?

The top searched job categories for Overnight Biotech Quality Control jobs in Indiana are:

What cities in Indiana are hiring for Overnight Biotech Quality Control jobs?

Cities in Indiana with the most Overnight Biotech Quality Control job openings:

Overnight Biotech Quality Control jobs near you

Senior Scientist, Quality CMC

Aquestive Therapeutics

Portage, IN • On-site

Full-time

Re-posted 23 days ago

Job description

Job Summary:
The Senior Scientist, CMC Quality, bridges analytical science and product performance, providing scientific leadership to distinguish analytical artifacts from true product, process, or manufacturing risks. This role drives complex investigations, informs quality-critical decisions, and partners cross-functionally to ensure sound, risk-based outcomes throughout the product lifecycle.
Responsibilities:
  • Serve as QC's primary interface to AR&D and Engineering, connecting analytical findings to process variability, formulation behavior, manufacturing deviations.
  • Support PQR/APQR product quality narratives, stability trend interpretation.
  • Lead and provide scientific oversight for complex OOS, OOT, deviation, and product quality investigations, determining whether observations arise from analytical, sampling, product, or manufacturing-related factors.
  • Lead the development and review of technically complex investigations, risk assessments, scientific rationales, and regulatory support documentation.
  • Provide independent, evidence-based scientific recommendations to support Quality decision-making and governance.
  • Understand method capability vs. product behavior.
  • Identify when method limitations drive variability, specifications may not reflect true capability, escalating systemic or recurring issues (i.e., lifecycle management).
  • Lead or support analytical and CMC quality improvement projects, as assigned.
  • Provide scientific assessment of stability trends, out of trend (OOT results), and potential impact to product quality.
  • Partner with Quality, AR&D and Regulatory to support IND/NDA/MAA submissions, post-approval commitments and annual updates.
  • Develop hypothesis-driven investigation strategies grounded in product behavior or formulation/process knowledge.
  • Drive root cause analysis and scientifically sound CAPAs.
  • Mentor junior scientists and provide technical guidance during investigations and problem-solving activities.

Qualifications:
  • BS in Chemistry, Pharmaceutical Sciences, or related field required.
  • Minimum of 8 years in pharmaceutical/biotech Quality Control, Chemistry, Manufacturing Controls (CMC), or Analytical Sciences
  • Demonstrated ownership of complex OOS, OOT, and deviation investigations, including: developing investigation strategies, performing root cause analysis, defending conclusions and CAPAs
  • Significant experience in: Cross-functional investigations involving QC, Manufacturing, QA, and AR&D
  • Significant experience in interpreting analytical data in the context of product quality and process performance
  • Significant experience in stability programs, trend analysis, and product performance evaluation
  • Significant experience in analytical method capability, variability, and limitations
  • Strong understanding of: CMC development and commercialization, GMP and global regulatory expectations (FDA, EMA, ICH), OOS/OOT investigation frameworks and industry best practices
  • Demonstrated ability to: influence cross-functional teams without authority, articulate and defend scientific positions in QA and leadership forums
  • Strong business and product acumen, with understanding of: impact of quality decisions on supply, regulatory risk, and product lifecycle
  • Experience supporting regulatory submissions (IND/NDA/MAA), inspections, or audits preferred
  • Experience with instrumental techniques such as GC, HPLC, Dissolution.
  • Some travel required

The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.
As part of Aquestive's employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.
Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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