Location: Buena, NJ
Responsible for the coordination of Shared Services between Sterile and Topical Operations within the Quality Assurance department in Buena, NJ. The Quality Assurance Group Leader ensures compliance with regulations governing the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products. This position will support Teligent’s overall cGMP compliance and the day-to-day performance of drug product manufacturing.
3-5 direct reports
- Perform internal Quality inspections of Shared Resource Areas such as Warehouse Operations, Laboratories, Computer Systems as required.
- Support projects such as Utilities Validations, Qualifications of Shared Operations Equipment and new products as required.
- Review external vendor reports including Purified Water System maintenance, instrument calibration reports and pest control reports.
- Lead, support, and train staff regarding “on the floor” activities such as line clearances, product inspection, real-time document review, interim problem solving, etc.
- Understanding of GMP compliance and requirements as they apply to quality systems and company policies; experience with CFR Parts 11, 210, 211.
- Review of executed batch record documents and work with departments to address and correct issues in a timely manner
- Review and assign dispositions for materials and components used in batch manufacture in a timely manner in SAP and LIMS.
- Lead or assist in conducting manufacturing investigations; root cause analyses, risk assessments, and impact evaluations.
- Provides subject matter expert support, review and approval during meetings, audits, investigations, technical reports etc.
- Provide a positive and supportive environment within the department, and cross-collaborates with other departments.
- Trend and report batch record review and disposition metrics related to finished products.
- Drafts, reviews, and approves SOPs, protocols, and technical reports related to process improvements, computer, facility, method, and GMP Quality Systems.
- Keep Quality Assurance Manager and Director of Quality Assurance informed of all key quality findings and issues
- 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.
- Manages team work load, drives accountability, and provides direction when needed.
- Ensures proper shift hand-off communication to the other Shift Supervisor and the Management Team.
- 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
- High school degree required; Bachelor’s degree preferred. In lieu of Bachelor’s degree, 10+ years of relevant experience in Pharmaceutical Quality Assurance (or Bachelor’s degree 2-5 years’ experience)
- Ability to work on multiple projects and meet timelines
- Good written and oral communication.
- Demonstrate professionalism, cooperation and willingness to support team and company priorities. 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
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
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