What are the responsibilities and job description for the QC Incoming Technician position at Union Agener?
Position Description, Functions, Duties and Tasks:
- Performs AQL sampling of incoming components and PPM per PMAM. (i.e. labels, pre- printed cartons, components)
- Performs sampling, inventory, storage and annual inspection of Active Pharmaceutical Ingredients (APIs) and Components (barrel assemblies and plungers).
- Perform other laboratory tasks as need (e.g. FTIR, Blue Dye Preparation, BFE and Sheath Removal/Cannula Pull)
- Review/approval of approved artwork, PMAM, PMAR ad PMS.
- Review/approval of QC Incoming procedures and related documents (Protocols, change controls, etc).
- Provides technical support by involvement in SOP’s and Change control systems.
- Assists in the training and development of all team members in areas of cGMP compliance and on-the-job requirements.
- Reviews and approves SOPs and analytical data.
- Participates in quality audits as needed.
- Writing and revising SOP’s and specifications.
- Maintains appropriate equipment records, files, and logs according to SOP’s and appropriate regulatory requirements.
- Assists in the maintenance of laboratory requirements, including reagents and supplies.
- Performs all activities in a safe and conscientious manner.
- Maintains a clean environment and assists with periodic lab clean-ups, and moving of equipment and laboratory supplies.
- Able to handle change productively and handle other tasks as assigned.
Minimum Qualification (Education, Experience and/or Training, Required Certifications): Education:
- At a minimum, an Associate’s Degree in Science is required or a minimum of 3 years lab, QC
or QA experience.
Experience:
- Computer Skills (Excel, Word and SAP)
Preferred Skills:
- Good communications, planning, and organization skills
- Ability to work in a team environment. Demonstrated team approach to multidiscipline issues relating to quality
- Demonstrated strong oral and written communication and interpersonal interaction skills
- Responsible for maintaining a safe work environment and working safely
- Ability to manage change productivity, work independently and multi-task as assigned
Other Information:
- This position may require shift work
