Location: Buena, NJ
- Understand documentation processing as mandated through the change control quality system.
- Prepare, author and publish Methods and Specifications in the Laboratory Information System (LIMS)
- Prepare and publish SOPs.
- Prepare and publish Master Batch Records.
- Issue Logbooks and Job Aids.
- Prepare and process change controls to closure.
- Strong understanding of GMP compliance and requirements as they apply to quality systems; experience with 21 CFR Parts 210 and 211.
- Strong understanding of Chemistry, Manufacturing and Controls (CMC) documentation.
- Strong understanding of post-approval changes.
- Maintain and update Documentation Department SOPs.
- Prepare documentation metrics for Manager.
- Maintain and archive Master Documents.
- Audit Master Document archives
- Perform trending metrics and gather statistical information from LIMS and QMS on documentation.
- Provides subject matter expert support during audits with regards to Methods, Specifications and SOPs.
- Provide a positive, supportive and collaborative environment within the QA department.
- Work collaboratively with other departments.
- Keep Quality Assurance Documentation Manager informed of all quality findings, incidents and trends.
- Perform internal Quality audits 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
- Bachelor’s degree in the sciences, with 2-5 years of pharmaceutical or related experience preferred
- 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.