STAQ Pharma
STAQ Pharma
Full-Time, Salary
Denver
Posted 2 weeks ago
Schedule: Monday to Friday, 2 PM until done
Pay: $55K/Year+, DOE
Summary | Effectively encourage and motivate associates to be successful and remain focused on Quality, Transparency, Safety and Availability objectives compatible with the company’s mission and vision. Responsible for providing oversight of the Quality System; including managing control of documents (SOPs, WI, Specifications, Batch Records, etc.) that impact the identity, strength, quality, and purity of finished product, and providing support on Quality management projects. |
Roles and Responsibilities | Lead the document control program to ensure procedures meet CGMP requirementsManage training documentation and track employee compliance with training plansIssue GMP documents including Master Batch Production Records, Room and Equipment Logs, Document Change Orders, etc.Support in-process and finished product lot acceptance sampling and inspectionParticipate in investigations and problem solving of raw material, in-process, and finished product non-conformances with production personnel and/or supplierDevelop and implement corrective and preventive actions geared toward continuous process improvementsSupport the finished product label printing and issuance processWrite and implement standard operating procedures to meet and maintain FDA cGMP, USP, and state licensure requirementsProvide supplier related support to production and receiving inspection teamOther duties and tasks, as assigned |
Qualifications and Education Requirements | 2-5 years of Quality Assurance experiencePharmaceutical, Medical Device, or biotechnology industry experience, preferably in support of manufacturingB.S. or B.A. on Sciences or a relevant field or equivalent experienceProfessional certification in Quality Engineering or Quality Auditing, preferred |
Preferred Skills | Excellent independent judgement and interpersonal skillsExcellent mathematical, written communication, and verbal communication skills Strong technical writing skills and attention to detailKnowledge of and proficiency in the use of basic statisticsFamiliarity with Good Manufacturing Practices and FDA RegulationsSupplier Auditing experience Knowledge of ERP System Proficient in using Microsoft Word, Excel, PowerPoint, Outlook: experience with OneNote and Publisher a plus |
Additional Notes | This position will work closely with the Production team and report quality data to the department head, as needed |