Location: Buena, NJ
Reporting Relationships: Individual Contributor
- Possess a strong understanding of GMP compliance and requirements as they apply to quality systems.
- Strong understanding of 21 CFR parts 210 and 211.
- Strong understanding of working with controlled documents in a cGMP regulated environment.
- Processes, publishes and archives controlled documents including Standard Operating Procedures (SOPs), Methods, Specifications and Protocols per Company procedures.
- Processes and prepares investigation reports on Customer Complaints.
- Prepares metrics on change control and other quality systems.
- Process Change Controls from initiation through closure.
- Maintains controlled documents in an audit ready format and in a readily retrievable status.
- Maintains tracking spreadsheets and logbooks used by QA Doc Control. Assigns and archives logbooks from other departments as required.
- Reviews and compiles data from Quality Systems including change controls, deviations and CAPAs and for distributed products from SAP and LIMS.
- Provides subject matter expert (SME) support during audits with regards to Quality Documentation.
- Maintains Quality Assurance Documentation Manager and Director of Quality Assurance informed of all adverse product quality findings and trends.
- Performs 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.
- Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities
- Bachelor’s degree in a related science (Chemistry, Biology, Physics, Life Sciences, Engineering, etc.).
- Minimum of 10 years’ experience in the pharmaceutical, life sciences, chemical, or similar industry.
- Solid Demonstrated ability to work on multiple projects and meet timelines.
- Knowledge of cGMP requirements. Practical experience with document control, and QA support in pharmaceutical manufacturing.
- Works collaboratively with other in the department and with other departments.
- Must have a positive, supportive and can-do attitude.
- Strong knowledge of Microsoft Word, Excel and Acrobat (PDF) documentation systems.
- Experience with LIMS administration activities desirable.
- Must be reliable with respect to accuracy and completeness of work assignments.
- Must be 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.
- Trending experience preferred.
- Adheres to Teligent’s standards of business conduct.
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.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- The employee frequently is required to stand; walk; use hands to handle or feel; and reach with hands and arms.
- The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.