Quality Control Analyst II Position
4 weeks ago
At BioSpace, Inc., we are seeking a highly skilled Quality Control Analyst II to join our team. As a Quality Control Analyst II, you will play a critical role in ensuring the highest standards of quality and consistency throughout the production process.
About the Role:
As a Quality Control Analyst II, you will be responsible for leading a team of analysts, ensuring compliance with local, global, and regulatory standards are maintained. You will support safety, customer satisfaction, employee development, and continuous improvement, consistent with plant goals. Additionally, the Lead Analyst leads a team of QC professionals, conducting root cause analysis for defects, collaborating with cross-functional teams, and driving continuous improvement efforts to optimize quality and efficiency.
Key Responsibilities:
- Lead ongoing, daily departmental operations.
- May include the guidance of assigned personnel in achieving defined quality goals. Interview/hire, evaluate, train, and develop direct reports.
- Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques. Determine the logic, adequacy and effectiveness of systems and related requirements. Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.
- Write, review, analyze, and revise written Standard Operating Procedures (SOPs) and submit procedural changes to meet Corporate, Divisional, Plant, Regulatory Requirements.
- Navigate, answer alerts and review Batch Records in EBM.
- Provide necessary floor support to the manufacturing teams and help in resolving compliance concerns.
- Support external audits.
- Help with audits of multiple reports (Protocols, Qualifications, Regulatory Submissions).
- Be a Subject Matter Expert (SME) and provide training to local employees on relevant area(s).
- Identify when proper practices/procedures are not performed. Follow SOPs and identify processes and results.
- Implement changes and corrections. Escalate accordingly. Ensure communication of issues.
- Ensure communications between personnel, groups, and between departments.
- Coordinate activities and schedules staff.
Requirements:
- Requires bachelor's degree in science, engineering or other related technical field. 2+ years of related experience.
- Proficient in wet and instrumental methods of analyses.
- Advanced laboratory skills and basic knowledge of statistical method.
- Must demonstrate effectiveness in ability to train others.
- Knowledge of most laboratory equipment including autoclaves, incubators and analytical equipment.
- Must be proficient in multiple mathematical operations and calculations and be able to work with both the metric and US standards of measurements.
- Will read and follow detailed written instructions and have good verbal/written communication skills.
- Knowledge of basic chemical and biological safety procedures.
- Knowledge of Microsoft Word, Excel and PowerPoint.
Important Considerations:
At BioSpace, Inc., our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
- In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility.
- May wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
- Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work supplemental hours.
- Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
- Must be able to lift, push, pull and carry up to approximately 25lbs.
- Will work in controlled environments requiring special gowning. Will follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
- Will work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.
- May work or be assigned to a different shift to meet needs. Must be willing to work off shifts hours.
- Will work supplemental hours to complete work commitments.
- May be required to work in a confined area.
- Inside working conditions.
- Some clean room and cool/hot storage conditions
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