Location: Buena, NJ
To provide a safe and healthy work environment for all of our employees and contractors, Teligent has mandated that all employees be fully vaccinated for COVID-19. This means that all new hires will be required to be fully vaccinated prior to their start date. We are taking this proactive step as our community continues to be negatively impacted by the pandemic and the surging Delta variant. Should you require a religious or medical accommodation, please inquire about necessary steps to secure such accommodations.
The Controlled Document & Batch Record Coordinator is responsible for issuing and reconciling lot specific batch records. Oversees issuance and storage of electronic copy of controlled documents. Assists with other Quality Assurance Documentation functions as needed to maintain department compliance.
Reporting Relationships: Individual Contributor
- Issues batch records to production as mandated by the production schedule.
- Performs audits of the batch record log book to verify all batch records are properly accounted for.
- Oversees the Archive Room for storage of numerous documents including SOPs, Specifications, batch records and numerous other documents.
- Oversees the storage of documents on the Controlled Document Server.
- Supplies electronic copies of controlled documents to Teligent staff on an as needed basis.
- Issues log books to the site on an as needed basis.
- Controls distribution or correct labels and associated batch record documentation to packaging lines.
- Investigates discrepancies.
- Complies with company policies and procedures.
- Keeps manager informed of all key quality findings and issues.
- Other duties as assigned.
Education and/or Work Experience Requirements:
- HS diploma with 3 to 5 years of QA or packaging experience.
- Demonstrated ability to work on multiple projects and meet timelines.
- Knowledge of cGMP requirements.
- Basic mathematical skills.
- Basic computer skills including the use of Word® and Excel®.
- Excellent organizational skills.
- Detail oriented.
- Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities.
- Well-developed interpersonal skills. Ability to get along with diverse personalities.
- Good written and oral communication skills.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- Employee is frequently required to stand for long periods of time; walk; use hands to handle or feel; and reach with hands and arms.
- 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.
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.