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Biotechnology: Quality Control and Assurance Job Description Templates

  1. Quality Control Specialist

Title: Quality Control Specialist (Biotechnology) Location: [Company Location] Employment Type: Full-time

Job Description: We are seeking a meticulous and detail-oriented Quality Control Specialist to join our Quality Assurance (QA) team. The Quality Control Specialist will be responsible for ensuring the quality and safety of our biopharmaceutical products through rigorous testing and analysis. This role offers an exciting opportunity to contribute to the quality management system and uphold regulatory compliance standards in the biotechnology industry.

Responsibilities:

  • Perform quality control testing of biotechnology products using established protocols and procedures.
  • Conduct analytical testing, including chromatography, spectrophotometry, and microbiological assays, to assess product quality and purity.
  • Interpret test results, identify deviations, and investigate root causes of non-conformances.
  • Maintain accurate documentation of testing procedures, results, and deviations in compliance with regulatory requirements.
  • Collaborate with cross-functional teams to address quality issues, implement corrective and preventive actions, and ensure continuous improvement of quality processes.

Qualifications:

  • Bachelor’s or master’s degree in biochemistry, chemistry, biology, or a related field.
  • Hands-on experience in quality control testing within a biopharmaceutical or biotechnology company.
  • Knowledge of regulatory requirements, including FDA regulations and Good Manufacturing Practice (GMP) guidelines.
  • Familiarity with analytical techniques and instrumentation, such as HPLC, GC, UV-Vis, and microbial testing methods.
  • Strong attention to detail, problem-solving skills, and the ability to work independently and collaboratively in a team environment.
  1. Quality Assurance Manager

Title: Quality Assurance Manager (Biotechnology) Location: [Company Location] Employment Type: Full-time

Job Description: We are looking for an experienced and proactive Quality Assurance Manager to lead our Quality Assurance (QA) team. The Quality Assurance Manager will be responsible for developing and implementing quality management systems, policies, and procedures to ensure compliance with regulatory standards and industry best practices. This role offers an excellent opportunity to drive quality excellence and continuous improvement initiatives in the biotechnology sector.

Responsibilities:

  • Develop and maintain quality management systems (QMS) in accordance with ISO standards and regulatory requirements.
  • Establish and enforce quality assurance policies, procedures, and standards to ensure consistency and compliance across all operations.
  • Conduct internal audits and assessments to evaluate the effectiveness of quality systems and identify areas for improvement.
  • Lead investigations into quality issues, non-conformances, and customer complaints, and implement corrective and preventive actions (CAPAs).
  • Provide guidance and support to cross-functional teams on quality-related matters, including product development, manufacturing, and regulatory affairs.

Qualifications:

  • Bachelor’s or master’s degree in quality management, life sciences, engineering, or a related field.
  • Proven experience in quality assurance management within the biotechnology or pharmaceutical industry.
  • In-depth knowledge of quality management principles, regulations, and standards, such as ISO 9001, ISO 13485, and cGMP.
  • Strong leadership and interpersonal skills, with the ability to effectively communicate and collaborate with stakeholders at all levels.
  • Excellent problem-solving abilities, analytical skills, and attention to detail.
  1. Regulatory Affairs Specialist

Title: Regulatory Affairs Specialist (Biotechnology) Location: [Company Location] Employment Type: Full-time

Job Description: We are seeking a dedicated and knowledgeable Regulatory Affairs Specialist to join our regulatory affairs team. The Regulatory Affairs Specialist will be responsible for managing regulatory submissions, ensuring compliance with applicable regulations, and supporting product registration activities. This role offers an exciting opportunity to contribute to the successful commercialization of biotechnological products and therapies.

Responsibilities:

  • Prepare and submit regulatory filings, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
  • Review and interpret regulatory guidelines and requirements to ensure compliance with FDA, EMA, and other regulatory authorities.
  • Coordinate regulatory submissions and interactions with regulatory agencies, including responding to requests for information and participating in meetings.
  • Support product development teams in the planning and execution of regulatory strategies and risk assessments.
  • Maintain regulatory documentation, records, and databases in accordance with regulatory standards and internal procedures.

Qualifications:

  • Bachelor’s or master’s degree in regulatory affairs, life sciences, pharmacy, or a related field.
  • Prior experience in regulatory affairs within the biotechnology or pharmaceutical industry.
  • Knowledge of FDA regulations, ICH guidelines, and international regulatory requirements.
  • Strong attention to detail, organizational skills, and the ability to manage multiple projects simultaneously.
  • Excellent communication and interpersonal skills, with the ability to work collaboratively in cross-functional teams.
  1. Validation Engineer

Title: Validation Engineer (Biotechnology) Location: [Company Location] Employment Type: Full-time

Job Description: We are looking for a skilled and experienced Validation Engineer to join our validation team. The Validation Engineer will be responsible for planning, executing, and documenting validation activities for equipment, processes, and systems in compliance with regulatory requirements and industry standards. This role offers an exciting opportunity to contribute to the validation of biotechnological manufacturing processes and ensure product quality and safety.

Responsibilities:

  • Develop and execute validation protocols for equipment qualification, process validation, and computerized system validation (CSV).
  • Perform risk assessments and impact analyses to determine validation requirements and acceptance criteria.
  • Collect and analyze validation data, prepare validation reports, and maintain validation documentation in accordance with regulatory standards.
  • Coordinate validation activities with cross-functional teams, including manufacturing, engineering, quality assurance, and regulatory affairs.
  • Support regulatory inspections and audits by providing validation documentation and responding to inquiries as needed.

Qualifications:

  • Bachelor’s or master’s degree in engineering, pharmaceutical sciences, or a related field.
  • Previous experience in validation engineering within the biotechnology, pharmaceutical, or medical device industry.
  • Knowledge of validation principles, regulations, and guidelines, including FDA 21 CFR Part 11 and EU Annex 15.
  • Familiarity with validation techniques and methodologies, such as IQ/OQ/PQ, process capability analysis, and risk-based validation approaches.
  • Strong analytical skills, problem-solving abilities, and attention to detail.

These comprehensive job descriptions can be customized to meet the specific requirements of your company and the roles you are hiring for in the biotechnology sector.

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