What are the responsibilities and job description for the Quality Control Specialist position at Systems Ally?
No C2C.
We are seeking a highly skilled Quality Specialist to join our team in Massachusetts. This role will support quality operations within the pharmaceutical and medical device industry, ensuring compliance with cGMPs, regulatory requirements, and quality systems. The ideal candidate will have a strong background in quality assurance, compliance, audits, and analytical testing, including expertise in HPLC, UV-VIS, fluorescence, ELISA, and assays.
Key Responsibilities:
- Ensure compliance with cGMPs, FDA, ISO 13485, and other regulatory requirements.
- Develop, implement, and maintain Quality Systems including deviation management, CAPA, change control, document control, and risk management.
- Conduct internal and external audits, ensuring adherence to regulatory and company standards.
- Investigate non-conformances, deviations, and CAPAs, ensuring timely resolution and root cause analysis.
- Support CMC Drug Product Development, ensuring quality oversight in formulation, process development, and scale-up activities.
- Perform analytical testing using HPLC, UV-VIS, fluorescence, and ELISA assays to support product quality.
- Collaborate cross-functionally with R&D, Manufacturing, and Regulatory teams to drive continuous improvement and compliance.
- Author and review SOPs, validation reports, and regulatory submissions.
- Participate in inspections and interactions with regulatory agencies.
Required Qualifications:
- Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biomedical Engineering, or a related field.
- 3-7 years of experience in Quality Assurance, Quality Control, or Compliance within the pharmaceutical and/or medical device industry.
- Strong knowledge of cGMPs, Quality Systems, CAPA, deviation investigations, and regulatory compliance.
- Hands-on experience with HPLC, UV-VIS, fluorescence, ELISA, and other bioanalytical assays.
- Experience in CMC Drug Product Development and understanding of analytical testing requirements.
- Ability to conduct audits and interact with regulatory bodies such as FDA, EMA, and ISO certification agencies.
- Strong problem-solving, technical writing, and communication skills.
Preferred Qualifications:
- Experience with ISO 13485, ICH guidelines, and risk-based quality approaches.
- Certification in ASQ (CQE, CQA) or similar quality certifications.
- Experience working with biologics, combination products, or sterile manufacturing environments.
- Knowledge of data integrity, statistical analysis, and validation methodologies.
