Sr. QA Associate

Corden Pharma Colorado• Boulder, CO, US, CO

13h•Onsite

About The Position

CordenPharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives. Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being. Our People Vision: We strive for excellence. We share our passion. Together, we make a difference in patients' lives. This role administers Quality Assurance programs, procedures, and controls ensuring that performance and quality of products conform to established Corden standards and federal regulations. It works directly with manufacturing and support groups to address quality issues with cGMP activities. The role participates in validation activities related to processes and computer-related systems, as well as general QA areas of responsibility.

Requirements

Knowledge of cGMPs, GDPs, and Corden Quality SOPs, and guidelines as they apply to documentation protocol and validation activities
Knowledge of process protocols, batch record requirements, and deviation reporting adequacy
Ability to apply attention to detail and regulatory requirements; and a practical, defendable, and logical approach to problem solving
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to write reports, business correspondence, and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to speak, read, and write in English.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables.
Knowledgeable of federal and corporate regulations; Chemical Manufacturing; Good Manufacturing Practices and Good Documentation Practices regulations and interpretations
Computer related experience
Process, computer, and equipment validation experience

Nice To Haves

Willing to work different shifts

Responsibilities

Reviewing Validation, Qualification, and Change Control Documents for adequacy and adherence to cGMPs and Corden SOPs
Acting as the QA Representative on project teams as needed
Serving as the QA Generalist and resource on cGMP issues, understanding cGMP, Data Integrity, and GDP requirements and expectations
Participating in customer audits and regulatory inspections, which may include defending systems, formulating responses, or owning associated CAPA records
Reviews completed/executed batch records in support of lot release
Compiling supporting data/information for lot release
Issuing batch records and associated labels, by ensuring the copy is a replicate of the master production instructions for each intermediate and API
Reviewing and approving stability reports, SOP/document revisions, methods, specifications, validation documents, and miscellaneous cGMP documents that require QA approval
Serving as the backup Administrator for the QA Documentation Specialist of the Quality Department, which includes managing the records database (TabFusion) and off-site records storage (Iron Mountain)
Serving as overall back up to other Quality personnel as appropriate
Provides guidance and leadership where appropriate, based upon the results of the documentation review process.
Responsible for participating in the budget process for input as required.
Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.
Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.
cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.

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 Paternal Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance