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Manager Biotech Quality Control Jobs in Indiana (NOW HIRING)

HTSG

QC Manager

Sullivan, IN · On-site

$60 - $70/hr

Position Title: QA/QC Manager - Electrical Location: Sullivan, Indiana Compensation: $60-$70/hr. | Per Diem: $4,515 | Hourly W2 Full Time | OT after 40 hours | Benefits: Health, Vision, Dental ...

H.B Fuller

Quality Control Manager

South Bend, IN

The QC Manager plans and coordinates activities of the QC lab and is accountable for timely and accurate test reports and product disposition. The QC Manager coordinates and leads all quality control ...

H.B. Fuller Company

Quality Control Manager

South Bend, IN · On-site

$85K - $115K/yr

The QC Manager plans and coordinates activities of the QC lab and is accountable for timely and accurate test reports and product disposition. The QC Manager coordinates and leads all quality control ...

Clayco

Quality Manager

Indianapolis, IN · On-site

Deliver daily QC reports aligned with project quality standards. * Collaborate with the project team to develop and implement the Quality Program. * Provide executive management with ongoing updates ...

Clayco

Quality Manager

Hobart, IN · On-site

Deliver daily QC reports aligned with project quality standards. * Collaborate with the project team to develop and implement the Quality Program. * Provide executive management with ongoing updates ...

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Manager Biotech Quality Control information

What is the difference between Manager Biotech Quality Control vs Quality Control Specialist?

AspectManager Biotech Quality ControlQuality Control Specialist
CredentialsBachelor's/Master's in Life Sciences, Quality Certifications (e.g., CQE)Bachelor's in Life Sciences or related field, Quality Certifications preferred
Work EnvironmentOversees QC teams, manages testing processes, and ensures compliancePerforms testing, data analysis, and reports results
Employer & Industry UsageBiotech companies, pharmaceutical firms, contract labsBiotech, pharma, and manufacturing sectors

The Manager Biotech Quality Control typically oversees testing teams and ensures compliance with quality standards, while the Quality Control Specialist focuses on executing tests and analyzing data. Both roles require relevant scientific credentials, but the manager has additional responsibilities in team leadership and process management.

What does a manager biotech quality control do?

A Manager Biotech Quality Control oversees the quality assurance processes within a biotechnology company, ensuring that products meet regulatory standards and internal specifications. They manage teams responsible for testing raw materials, in-process samples, and finished products, and analyze data to identify trends or issues. This role also involves setting quality control policies, training staff, and liaising with regulatory bodies to maintain compliance. Managers in this field play a crucial role in product safety and efficacy, directly impacting the success of biotech products in the market.

What are the most common challenges faced by a manager biotech quality control, and how are they typically addressed?

Managers in Biotech Quality Control often face challenges such as ensuring regulatory compliance, maintaining rigorous documentation, and managing a team with diverse expertise. Keeping up-to-date with changing industry standards and regulatory requirements is crucial, as is fostering a culture of continuous improvement and clear communication. These challenges are typically addressed through ongoing staff training, implementing robust quality management systems, and close collaboration with other departments like R&D and manufacturing to ensure that quality standards are consistently met.

What are the key skills and qualifications needed to thrive as a manager biotech quality control?

To thrive as a Manager Biotech Quality Control, you need a strong background in biology or chemistry, extensive knowledge of quality assurance regulations, and typically a bachelor’s or master’s degree in a life science field. Familiarity with laboratory information management systems (LIMS), GMP (Good Manufacturing Practices), and certifications such as ASQ or Six Sigma are highly valued. Leadership, attention to detail, and strong problem-solving and communication skills help you guide teams and ensure compliance. These skills and qualities are critical for maintaining product quality, regulatory adherence, and the overall success of biotech manufacturing operations.
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 Manager Biotech Quality Control jobs in Indiana? For Manager Biotech Quality Control jobs in Indiana, the most frequently searched job titles are:
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Manager Biotech Quality Control jobs near you

Senior Scientist, Quality CMC

Aquestive Therapeutics

Portage, IN • On-site

Full-time

Re-posted 9 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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