Location: Buena, NJ
The Quality Assurance Specialist, Annual Product Reviews ensures that Annual Product Reviews (APRs) are published for all products manufactured and/or distribution by Teligent Pharma Inc. This position will support Teligent’s overall cGMP compliance and drug product life cycle management compliance. Reports to the Quality Assurance Documentation Manager.
- Prepare, author and publish Annual Product Reviews for the Management Review Board
- Strong understanding of GMP compliance and requirements as they apply to quality systems; experience with CFR Parts 11, 210, 211.
- Strong understanding of Product Lifecycle, QbD and post-approval CMC changes
- Maintain and update APR SOP accordingly.
- Draft and publish an Annual Product Review for each Product Manufactured and/or distributed by Teligent Pharma Inc. on an annual basis.
- Perform materials management trending.
- Perform and document Product Retain Sample Inspections
- Prepare metrics on retain sample inspections
- Maintain Product Retain Sampling Program
- Review and gather data from Quality Systems including change controls, investigations and CAPAs for APRs.
- Review and gather data for distributed products from SAP and LIMS.
- Review and gather data for materials and components used in batch manufacture from SAP and LIMS.
- Perform trending metrics and gather statistical information from LIMS and QMS for APRs.
- Provides subject matter expert support during audits with regards to APRs.
- Provide a positive, supportive and collaborative environment within the QA department.
- Work collaboratively with other departments.
- Keep Quality Assurance Documentation Manager and Director of Quality Assurance informed of all adverse product quality findings and trends.
- Perform internal Quality inspections of Shared Resource Areas such as Warehouse Operations, Laboratories, Computer Systems as required.
- Perform other duties as assigned.
- Recognizes the need for urgency in the responsibilities and makes attempts to meet all requirements and deadlines.
- Takes initiative to identify and correct any areas of risks/gaps in the current quality systems.
- Is reliable with respect to accuracy and completeness of work assignments.
- Is reliable with respect to attendance schedule, on-time arrival and diligent/productive work ethic throughout the day.
- Excellent organizational and planning skills.
- Strong written, verbal, and interpersonal communication skills.
- High attention to detail.
- Demonstrated strong analytical skills, and the ability to work independently against competing deadlines.
- Adheres to Teligent’s standards of business conduct
- Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities
EDUCATION AND EXPERIENCE:
- HS Diploma and minimum of 5 years of experience in QA/QC (or Bachelor’s degree 2-5 years’ experience)
- Solid Demonstrated ability to work on multiple projects and meet timelines
- Knowledge of cGMP requirements. Practical experience with document control, and QA support of manufacturing
- Strong knowledge of Microsoft Word, Excel and Acrobat (PDF) documentation systems.
- SAP and LIMS experience preferred
- Trending experience preferred.
- While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.