Quality Inspector
Job DescriptionJob Description
Northwind Pharmaceuticals offers opportunities for career advancement and growth. Positive culture, great building, and family-owned company. We are expanding and currently looking to add a few talented associates.
Job Summary:
Principal Responsibilities:
· Review and approval of pre-execution packaging batch records for label printing to ensure CGMP compliance and adherence to P&Ps
· Inspection and review of in-house printed labeling for release to production, ensuring proper quality and compliance standards are met, as required.
· Perform in-process and post packaging quality inspection on all Packaging Lines
· Review and approval of drug product and packaging materials issued to packaging lot for accuracy prior to batch execution
· Inspection of Packaging Lines for cleaning / clearance verification, prior to batch execution
· Inspection, testing, and examination of packaging components, labeling materials, and bulk drug product to ensure proper quality and compliance standards are met
· Rejection of products that do not conform to required specification and follow up on any requirements to obtain product conformance.
· Assisting with equipment calibration program and monitoring; equipment qualification program and monitoring including maintenance of all applicable documentation.
· Assisting with maintenance of records and files for all finished goods including batch documentation for lot tracking
· Inspection of Retention Samples annually to ensure compliance and product quality is maintained
· Preparation and reconciliation of drug product waste for destruction as well as maintenance of drug product waste records
· Provide timely communication of quality issues to Quality Management as needed
· Participate in investigations, deviations, discrepancies, technical problems, procedures, complaints and non-conformance of materials and processes.
· Maintain a clean and organized operational area
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
Training, Skills, Knowledge and/or Experience:
· Good communication with Management teams, other support staff, and production teams.
- Up to 1-year experience to gain enough skill to perform the essential functions of the position within quality and quality standards.
- Perform basic functions of arithmetic: add, subtract, multiply and divide all units of measure.
- Perform reading, writing and speaking at a basic level.
- Ability to deal with problems involving standardized situations.
- Basic computer skills including Word, Excel and database software.
- Ability to understand and follow CGMP, P&Ps, FDA and DEA regulations.
- Exhibit and maintain good personal hygiene.
- Great attention to detail.
- Interpersonal skills.
- Comply with company policies and procedures.
- Follow safe working practices in the execution of assigned duties.
- Demonstrate initiative and ability to perform as part of a team.
Competencies
You will learn:
· Pharmacology Basics; Generic and brand names, therapeutic equivalence, drug interactions, strengths/dose, common and sever side or adverse effects, therapeutic contradictions associated with medications
· Medication Safety
· Pharmacy Quality Assurance
· Medication Order Entry and Fill Process
· Verbal Communication / Effective Telephone Communication techniques/etiquette
· Commitment to Client Services and Patient-Centered Care
· High Standards of Professionalism, Responsibility and Ethics
Working Conditions:
· Physical surroundings: Office environment, work conducted in Warehouse setting, Production floor (QA) duties.
· Adverse working environment:
· Physical Effort: General office environment duties, operating office equipment, ability to lift up to 35lbs., standing on feet for long periods of time, computer operations, clerical operations.
· Domestic/International Travel: N/A
Extensive Hours: Willing to work various shifts and/or extended hours when needed.Education, Licensure, Credentials and
Experience:
Highschool Diploma or GED equivalency required
Will provide on the job training to obtain Pharmacy Technician Certification, if desired
Employment Requirements:
At least 18 years of
Must pass pre-employment background check and drug screen
Demonstrate efficiency and accuracy at all times
Physical Requirements:
Physical standing for most of the shift, bending, lifting, stretching
Must be able to lift up to 15-30 pounds at times.
Must be able to do stairs.
Company DescriptionWe’ve got a job to do. Actually, we’ve got lots of jobs to do. Helping our employer clients do great things for their employees through their healthcare benefits is our purpose. Helping our patients live fuller, healthier, lives is our vocation. However, creating an environment in which we can all contribute, grow, and take care of our families, while fulfilling our purpose and our vocation, is the Northwind recipe for success.
If you want to be a part of something more than yourself, want to see how your work ties to that bigger purpose, need opportunities for personal, professional, and financial growth, feel that you are called to leave things better than you found them, and like to be on a winning team, Northwind might be the right place for you.Company DescriptionWe’ve got a job to do. Actually, we’ve got lots of jobs to do. Helping our employer clients do great things for their employees through their healthcare benefits is our purpose. Helping our patients live fuller, healthier, lives is our vocation. However, creating an environment in which we can all contribute, grow, and take care of our families, while fulfilling our purpose and our vocation, is the Northwind recipe for success.\r\n\r\nIf you want to be a part of something more than yourself, want to see how your work ties to that bigger purpose, need opportunities for personal, professional, and financial growth, feel that you are called to leave things better than you found them, and like to be on a winning team, Northwind might be the right place for you.