QC Specialist, Microbiology

Corden Pharma Colorado

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. SUMMARY Is responsible for administering the GMP Environmental Monitoring Program for the site for classified spaces for production, packaging, sampling, dispensing, and testing. This person will serve as a Subject Matter Expert for one or multiple microbiological programs.

Requirements

Bachelor's Degree (BA) from a four-year college or university in Microbiology
five years related experience and/or training
Ability to read and comprehend simple instructions, short correspondence, and memos.
Ability to write simple correspondence.
Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
Ability to calculate figures and amounts such as proportions, percentages, area, and volume.
Ability to apply concepts of basic algebra.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Strong math, reading, and comprehension skills
Mechanical aptitude with lab equipment
Support QC staff with general lab duties
Preform microbial methods on test samples
Good communication skills and computer skills
Commitment to Quality and SHE Principles
Ability to work closely with team members to a common goal
Attention to detail
Ability to work on 12 hour rotating shifts, night or day; weekends and holidays required

Responsibilities

Responsible for ensuring the operational nature and conformance of manufacturing spaces to meet stated requirements for protection of the product in regard to GMP.
Coordinates with safety personnel regarding industrial hygiene requirements and how they reflect into GMP requirements
Provides comments on user, functional, and design specifications for classified areas in conjunction with the cross functional QA team regarding recommended equipment, accessories, techniques and practices in clean room areas
Establishing, revising, and maintaining the GMP Environmental Monitoring Program for the site in accord with recognized standards and regulatory requirements
Responsible for the coordination, scheduling, execution, and review of work for on-going certification requirements to meet technical standards (ISO 14644 or other)
Responsible for ensuring environments and the supporting utilities (gas and water) are tested and compared to action and alert limits
Takes action to investigate and remediate areas to standard
Reviews operational procedures and ensures controls and practices are implemented to preserve the environment
Monitors activities and provides feedback to Operations and Production personnel on the activities that can cause non-conformance to specifications
Advises on personal protective equipment, surfaces, and equipment required to maintain viable and non-viable particulate to meet classified requirements
Reviews, participates, and authors risk assessments regarding environmental monitoring topics for operational areas in comparison to regulatory requirements, including customer inquiries
Able to work under minimal direction and possess the ability to work on complex problems by analyzing procedures and data to create appropriate solutions.
Isolates and makes cultures of significant bacteria or other micro-organisms in prescribed or standard inhibitory media, controlling factors such as moisture, aeration, temperature, and nutrition
Identifies micro-organisms by microscopic examination of physiological, morphological, and cultural characteristics
Performs endotoxin analysis using turbidimetric and gel clot methods on water and product samples
Maintains Micro Lab including supply ordering, sterilization, instrument maintenance, and calibration
Generates methods and standard operating procedures relevant to the Micro Lab
Participates in required investigations, including review of microbial deviation issues or risk assessments
Participates in Regulatory Audits
Attends and participates in QC Team meetings. Develops team’s skills
Site water activities including coordination of samples with external labs
Weekly water samples
Critical water samples for investigation to be performed on site
Investigation of samples
API samples for lot release for all products
Includes performing testing for TAMC/TYMC within 24 hours of receipt
Microbiological Program and Microbiological lab improvements for continuous improvement
Establishment and maintenance of 5S/Lean Lab Principles
Trains QC Staff on new Microbiological procedures and processes
Qualify new media
Viable and non-viable air sampling
Maintaining data sources and trending for the environments/utilities

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