Position Summary
The Quality Control Technician is responsible for knowing regulations and standard associated with pharmaceutical manufacturing including packaging and labeling. They are responsible for performing product inspections and or test during production to ensure compliance with production specifications, applicable regulations and SOPs. They are responsible for ensuring that all incoming product and components meets required specifications. Responsible for completing portions of the production batch record that are associated to the Quality Control functions.
Organizational Position
This post holder reports directly to the QA Director, or designee, but they will work closely with CalCog’s Client Services, Commercial, Operations, and Regulatory teams.
Responsibilities
- Ensure SOPs are followed to meet Quality Standards, including but not limited to Receiving and Production SOPs.
- Ensure proper use of Personal Protective Equipment.
- Collaborate and communicate with upper management and operations team on Quality related issues.
- Document and report all inspection results, reports all non-conformances related to specification or standard to Quality Management.
- Conducting test and or inspections of products and process to evaluate quality or performance.
- Work in conjunction with production to ensure the best possible product is being produced in accordance with GMPs and internal/external specifications.
- Perform visual inspection of finished product as required by procedure.
- File and maintain the archiving documentations.
- Responsible for verifying that incoming products comply with documents specification, including but not limited to, drugs, components and labels.
- Review pre and post-production batch records for to ensure compliance to regulatory and internal/external requirements.
- Assist with other Quality related functions as needed to support site productivity.
- During QC down time assist with other facility related tasks such as document scanning, warehouse cleaning and inspections.
- Other duties as assigned according to the changing needs of the business.
Qualifications, Experience, and Skills
- High school diploma or equivalent required
- Bachelors (preferred)
- Experience working with in a regulated environment (preferred)
- 1 year QC experience or the equivalent combination of education and related work experience in a GxP regulated employment setting totaling 1 years: Bachelor Degree +0-1years, Associate Degree +2 years or High School Diploma +3 years relevant work experience
Competencies, Traits and Skills
- Strong organizational skills with multitasking capabilities
- Ability to interpret and apply cGMP and company SOP knowledge
- Strong interpersonal skills and the ability to manage, motivate, and influence quality work behaviors in self and others
- Flexible, enthusiastic and highly motivated to work in a challenging environment
- Proficient knowledge of various computer applications to include Microsoft Office applications
- High attention to detail and statistical aptitude
- Position entails a high level of independence, initiative and requires an aptitude for attention to details