Job Title: Quality Control Specialist Job Function: Quality Control Therapy Area/Industry: Pharmaceutical Job Description: Proclinical is seeking a Quality Control Specialist to join our team.
The following information aims to provide potential candidates with a better understanding of the requirements for this role.
In this role, you will focus on ensuring the quality and compliance of incoming deliveries, supporting team members, and maintaining high standards in documentation and safety.
This position requires a proactive approach to continuous improvement and adherence to Good Manufacturing Practices (GMP).
Responsibilities:
- Work as a flexible and motivated team member.
- Follow all Standard Operating Procedures (SOPs) and Standard Work Instructions (SWI) applicable to your training.
- Act in compliance with Good Manufacturing Practices (GMP) and report any quality issues.
- Maintain safety standards in compliance with relevant legislation and use safety reporting systems to highlight potential hazards.
- Stay up to date with all training requirements, including classroom courses and computer-based training.
- Participate in Continuous Improvement (CI) activities to enhance equipment and processes.
- Engage in Root Cause Analysis (RCA) and Corrective and Preventative Action (CAPA) processes.
- Test and perform batch usage decisions on incoming deliveries before production use.
- Write and check methods and SOPs.
- Schedule activities and workload within the department.
- Support other team members.
- Handle vendor rejections.
- Document deviations from procedures and processes.
- Address artwork discrepancies.
- Monitor and report on performance.
- Perform inspections and validation.
- Support New Product Introduction (NPI) project activities.
- Review maintenance routines and LEFs.
- Arrange external testing with third-party labs.
- Collaborate with logistics and production areas to ensure components meet production requirements.
- File and archive documentation.
Key Skills and Requirements:
- Strong understanding of Good Manufacturing Practices (GMP).
- Ability to follow SOPs and SWIs accurately.
- Excellent communication and teamwork skills.
- Proficiency in safety standards and reporting systems.
- Commitment to continuous learning and improvement.
- Experience in Root Cause Analysis (RCA) and Corrective and Preventative Action (CAPA) processes.
- Attention to detail in documentation and quality control.
- Ability to manage schedules and workloads effectively.
- Familiarity with validation and inspection processes.
- Experience in supporting New Product Introduction (NPI) projects.
- Organizational skills for filing and archiving documentation.
Please apply on Linkedin.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.