Interested in joining the RMC Pharmaceutical Solutions team?
RMC Pharmaceutical Solutions is a small Bio/Pharma contract services company based in Longmont, Colorado that is financially secure, believes in a high quality of service to clients, and takes great care of their employees with the understanding of a work/life balance.
If your skills and career goals match our company we would look forward to the opportunity to review your resume.
Skills that RMC Pharmaceutical Solutions is seeking:
- Analyze and draft stability reports
- Protein process development skills and knowledge
- Assist in development, review and execution of SOPs
- Execute validation protocols
- Research manufacturers by web and phone screenings
- Review bioanalytical method validation reports
- Assist in execution of operational and installation qualification protocols for clean room
- Development of SOPs
- Participate in client conference calls (prepare powerpoint)
- Evaluation, development, implementation and/or management of Quality Systems
- (QA&QC) for GMP integrated operations and GxP (i.e. GMP/GLP/GCP) outsourced
- operations
- Product categories: bulk and finished pharmaceuticals (i.e. dry powder & liquid
- injectables and solid oral dosage) and medical devices
- Regulations, guidance and compendia: US GxP, ICH, EU GMP Rules Volume 4 Annex 13 & 18, USP, Ph. Eur.
- Perform release activities for bulk substance, final product (including labeling and
- packaging operations of clinical trial materials), devices and coordination of contract QP
- release for EU distribution, including Batch review records.
- Internal and external GMP audits and general GxP quality systems audits and
- assessments (IND/NDA CMC & clinical data/information submissions).
- Validation activities related to analytical, process and equipment
- GxP Training program development and administration
- Routine analytical skills in the laboratory such as HPLC
- Record review/resolution for batch records, testing records, deviation/investigations,
- validation protocols/reports, change control, development reports
- Labeling, raw material, warehousing, facility and equipment control systems
- Draft specifications for raw materials, bulk substance and final dosage forms
- Draft/review/execute protocols and reports for stability, analytical and process validation, equipment IQ/OQ/PQ
- Coordinate the resolution of complaints, deviations and QC laboratory investigations
If you're interested in applying for a career opportunity
with RMC or have additional questions, please email your resume
and cover letter to humanresources@rmcpharma.com. |
