Sr. QA Product Specialist

Corden Pharma Colorado

6h•Onsite

About The Position

Provides Quality Assurance related product leadership as it relates to planning and execution of customer projects. Responsible for the collaboration, review, and approval of GMP documents needed for products. Represents the highest level of GMP understanding and accomplishment and demonstrated technical knowledge as it relates to cGMP Operations. Responsible for providing strong Quality leadership and scientific/GMP information support as the Quality Representative supporting the lifecycle of products for internal and external customers.

Requirements

Bachelor’s Degree in Science and 8 years of Quality Assurance experience within the Pharmaceutical Industry; or a combination of Pharmaceutical Industry within a Technical/Operations role and academic experience.
Experience in a product decision-making is required.
Ability to read, analyze, and interpret common scientific and analytical journals.
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Ability to communicate information to customers and senior management.
Ability to effectively present information to top management and public groups.
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
Excellent customer service skills
Knowledge of cGMP, cGLP, and FDA regulations, as well as internal Quality related procedures
Practical and theoretical knowledge of the basic principle of validation and their applications
Analytical ability and ability to influence
Excellent verbal, presentation, and written communication skills
Ability to provide leadership in all aspects of QA/development processes
Analytical skills with the ability to function in an interactive interdisciplinary team environment
Proactive approach to problem-solving and resolution

Nice To Haves

Project Management experience, although not required, is beneficial to this position.

Responsibilities

Knowledgeable in regulations including, but not limited to, ICH Q7 – Q13, 21 CFR Parts 210, 211, 600, applicable USP requirements, and in cleanroom requirements as it applies to Annex 1
Represents QA for Quality related customer interactions for one or more products. Responsible for clear, direct, and appropriate communication in customer interactions
Provides Quality leadership and decision-making on cross-functional teams that include, but are not limited to, Operations, Process Engineering, Process Development, Analytical Development, Safety, and other Quality functions
Serve as process Quality Team representative on capital improvement projects
Provides process support including clinical development, process validation, technical transfer, and commercial activities
Collaborate, review, and approve all phase-appropriate product-related Change Controls, Master Batch Records, Validation Protocols and Reports, Quality Risk Assessments, Annual Product Quality Reviews, and other cGMP documentation
Author and approve internal documentation including, but not limited to, training documents, work instructions, and Standard Operating Procedures (SOPs)
Collaborate, review, and approve all levels of investigations (including major and critical investigations) and Corrective Actions Preventative Actions (CAPAs)
Create, report, and communicate quality metrics to internal and external stakeholders
Assure that manufacturing processes, packaging, and testing comply with all regulatory filings and Corden SOPs, to ensure favorable quality inspections and customer satisfaction
Perform final product batch disposition
Assist in and represent Quality during internal and external audits and regulatory inspections. May lead audits and inspections as needed
Lead efforts that support CordenPharma initiatives and improvements. Knowledgeable in Operational Excellence

Benefits

401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
Accident Plan
Critical Illness Insurance
Dental Insurance
Disability Insurance
Employee Assistance Program
Flexible Spending Account
Health Insurance PPO/HSA
Hospital Indemnity Plan
ID Theft Protection
Life Insurance
Paid Parental Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance