What are the responsibilities and job description for the Sr Quality Ops Analyst position at Planet Pharma?
Target Pay Range: 43.50–54.25/hr DOE
Responsibilities
Requirements
Responsibilities
- Manage the document control program and identify, recommend, and implement process improvements.
- Analyze, process, and track Change Requests (CRs) and Change Orders (COs) in Ensur.
- Write, edit, review, and maintain controlled documentation, including WIs, policies, procedures, and change management records for Laboratory Services (ILS).
- Perform document control activities, including document processing, distribution of controlled copies, and filing using manual and electronic systems in accordance with established procedures.
- Monitor change activity approvals and implementations; proactively identify and resolve issues of varying complexity.
- Facilitate records management activities, including retention and archival, ensuring compliance with applicable regulations.
- Maintain personnel records within the quality system.
- Assign document-related training based on management requests and departmental training matrices and plans.
- Create, maintain, and update organizational training matrices in collaboration with management.
- Track, trend, and report on document-related training compliance.
- Communicate and deliver training to users as required.
- Manage or support the training program and continuously improve training processes.
- Support competency assessment tracking and periodic training records review.
- Collaborate cross-functionally and with other sites and external partners to implement new processes and promote awareness of quality policies and procedures.
- Monitor quality system process metrics and develop or support corrective action plans as needed.
- Identify opportunities for business process improvement through analysis, tracking, and trending of quality inputs and review data.
- Provide management with regular status updates on assigned responsibilities and escalate risks or issues in a timely manner.
- Support supplier management activities.
- Provide PDP (Product Development Process) support and drive PDP continuous improvement initiatives.
- Support research collaboration studies.
- Perform miscellaneous quality system tasks, including Work Instruction (WI) reviews and change management reviews.
- Perform other duties as assigned by management.
Requirements
- Quality certification preferred (e.g., CQE, CQA).
- Minimum of 5 years of experience in a Quality Assurance role within a regulated environment; direct experience in in-vitro diagnostic (IVD) manufacturing strongly preferred.
- Demonstrated experience applying quality regulations and standards, including:
- 21 CFR Part 820
- ISO 13485
- ISO 14971
- CLIA, CAP, CLEP
- Practical experience in process improvement, risk management, validation, change control, and supplier quality.
- Strong organizational and task management skills, with the ability to manage multiple priorities effectively.
- Experience using quality and statistical analysis tools, including SPC, risk analysis, FMEA, DOE, and trend analysis.
- Excellent interpersonal, written, and verbal communication skills.
- High attention to detail; well-organized and capable of working independently and in cross-functional teams.
- Strong critical thinking and problem-solving abilities.
- Proven ability to achieve goals while collaborating across departments in fast-paced corporate environments.
- Demonstrated experience working with complex Quality Management Systems (QMS) and ERP platforms (e.g., SAP, EtQ).
- Advanced proficiency in Microsoft Word and Excel; experience with tools such as LucidChart to perform data analysis, trend reporting, and development of process maps and procedures.