What are the responsibilities and job description for the QA Data Review Specialist (Pharmaceutical) position at UPM Pharmaceuticals?
QA Data Review Specialist (Pharmaceutical)
UPM Pharmaceuticals is an independent, highly experienced, and award-winning contract development and manufacturing organization (CDMO) located in Bristol, Tennessee. UPM Pharmaceutical’s mission is to advance Client formulation development efforts to the fullest extent possible with the ultimate goal of commercialization, all while adhering to strict standards of quality, timeliness, scientific fundamentals, and affordability.
Summary
Under the direction of QA Management, performs review of analytical data and calculations associated with but not limited to material testing and analytical method transfer, optimization, development and validation. Performs these goals by reviewing raw data, chromatograms, reports and results sheets, calculations, notebooks and logbooks associated with testing and generation of results in accordance with laboratory SOPs.
Essential Duties and Responsibilities:
1. Performs review of analytical data and calculations associated with, but not limited to material testing, analytical method transfer, optimization and development/validation design and analytical methods development/validation of drug substances, drug product and residual testing, using guidelines from USP and ICH and in accordance with laboratory SOPs.
2. Consults with scientific professionals and scientific literature for problem solving assistance.
3. Reviews documented laboratory activity and data filed in appropriate log books, records, files and equipment calibration logs.
4. Observes safety rules and assists in keeping the laboratory a safe environment.
5. Reviews laboratory equipment such as balances, pH-meters, HPLCs, and dissolution baths in the performance of required and scheduled test procedures and in accordance with laboratory SOPs.
6. Conducts peer reviews of other analytical chemists and scientists’ work prior to submission to quality assurance.
7. Reviews technical reports, protocols, final reports, stability reports and other forms of documentation as required. This will include the preparation and review of all data supporting regulatory filings, such as CMCs and NDAs; with the preparation, review, auditing and control of Methods Development documents including, but not limited to protocols, reports, laboratory notebooks, general practices, batch cards, test request, material specifications, certificates of analysis & compliance, and standard operating procedures; and to issue progress reports regarding the results and status of the review and audits of these documents.
8. Prepare progress reports regarding the status of the data packet reviews and quality findings in these documents and data release support systems.
9. Other duties as assigned.
Education / Experience:
Requires a BS in Chemistry or related scientific field and minimum 1 - 3 years of pharmaceutical experience using analytical instrumentation and/or data review experience. Knowledge of pharmaceutical GMP required. Equivalent combination of education and experience or training is acceptable.
To apply, email resume and salary requirements to humanresources@upm-inc.com
Qualified candidates must be legally authorized to be employed in the United States. UPM does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Relocation assistance
- Retirement plan
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Education:
- Bachelor's (Required)
Experience:
- Pharma Laboratory: 3 years (Required)
Work Location: In person
