- Responsible for all data generated from instruments such as HPLC, GC and other testing.
- Responsible for timely review of all analytical method results.
- Responsible for review of documentation such as analytical methods, protocols and reports.
- Review data for correctness and ensures that the documentation is as per cGMP requirements.
- Maintain and follow all laboratory systems, GMPS and safety requirements.
- Assist in the evaluation and interpretation experimental data.
- Compile, maintain, review and interpret analytical and statistical data. Assist with generating high quality technical documents required for method validation and ANDA submissions.
- Adhere to safety and housekeeping requirements.
- Prepare and review SOPs, as required.
- Keep supervisor informed of all key quality findings and issues. Seek guidance on resolution of complex issues
- Assume other activities and responsibilities as directed.
- Education: Bachelor’s degree in Chemistry, Engineering or other Physical Sciences.
- Minimum 2-5 years of experience in medical device and/or pharmaceutical QA or QC role.
- Working knowledge in the quality systems for the medical device and/or pharmaceutical industry.
- Working knowledge in FDA 21 CFR Parts 11, 210, 211 and 820 and ICH quality system requirements.
- Ability to work collaboratively in a professional and effective manner across all Teligent departments.
- Experience in using computer programs (MS Word, Excel, and Access).
- Strong verbal and written communication skills.
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.
- 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.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.