Senior QA Specialist, Compliance

Company Information

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

• engage in work that matters to our customers and the patients they serve
• learn new skills and enjoy new experiences in an engaging and safe environment
• strengthen connections with coworkers and the community

We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!

Job Overview

The Senior QA Specialist - Compliance is responsible for maintaining the site audit and compliance program. This position will report to the site Quality Head and will be responsible for the inspection readiness program for the site. Inspection readiness may include periodic internal audits, client audits, or any external regulatory health authority inspections. This person will be accountable for all aspects of the audit program including scheduling, hosting and coordinating with affected teams to provide appropriate responses to audit observations. The Senior QA Specialist - Compliance is responsible for ensuring closure of all identified corrective actions by the communicated commitment date. The Senior QA Specialist - Compliance will work collaboratively with other members of the Cambrex-Longmont site, and the client's functional areas and leadership teams to evaluate GMP/GDP business operations for compliance with health authority requirements, SOPs, and procedures, to ensure product quality and patient safety.

Responsibilities

• Manages the site audit programs (internal and client) including managing responses, as assigned.
• Generates/Evaluates audit responses to audit observations and ensure that proposed CAPA plans are suitable to address the observed deficiency and reduce risk to the business.
• Reviews evidence of CAPA completion and evaluate CAPA effectiveness during subsequent audits.
• Leads and drives continuous improvement of the audit program, and development of tools and processes utilized to facilitate the audit process
• Escalates issues to management in a timely manner implementing appropriate solutions, including preventative actions
• Interprets applicable quality regulations/standards and create appropriate policies and procedures
• Performs all responsibilities in accordance with applicable company guidelines, SOPs and appropriate industry and regulatory standards, guidelines, rules and regulations.
• Maintain current knowledge of applicable regulations, industry guidance, and best practices to ensure optimal execution of the audit program.
• Support site supplier qualification program.
• Creates strong and effective relationships with clients
• Participates and promotes a culture of quality
• Other duties as assigned

Qualifications/Skills

• Excellent attention to detail, as well as time and resource management.
• Excellent personnel and professional integrity and trustworthiness with strong work ethics and the
  ability to independently with minimal direction.
• Expertise in hosting regulatory and client audits to ensure compliance to regulatory requirements.
• Experience conducting audits of suppliers to ensure continued supplier quality and ensuring minimal
  disruption to the supply chain, ensuring continued manufacturing and testing processes.
• Demonstrated knowledge of global GMP and regulatory requirements related to the pharmaceutical
  drug development / manufacturing process.
• Advanced knowledge of FDA, EU, and ICH requirements and implementation for GLP and GMP in the
  pharmaceutical industry.
• Experience in documenting, analyzing, and responding to regulatory authorities in all areas of
  compliance.
• Strong knowledge and understanding of LIMS and Empower, required.
• Skilled in MasterControl, Trackwise and/or other QMS software applications.

Skills / Abilities:

• Good conflict management and technical skills
• Understanding of worldwide regulation and regulatory guidance
• Knowledge of cGMP and EMA requirements
• Experienced in client audits
• Proven ability to work with site quality and operations teams to maintain compliance
• Good analytical and problem-solving skills with the ability to think strategically
• Strong attention to detail, as well as time and resource management
• Strong personal and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction and a high degree of self-motivation.
• Promote a safe work environment
• Strong communication skills, both written and verbal for internal and external customers
• Ability to actively listen and process information to facilitate appropriate responses to external customers, partners, and colleagues at all levels.
• Understanding task prioritization based on business objectives
• Working knowledge and understanding of LIMS, electronic asset management systems, Trackwise, and MasterControl.
• Microsoft Suite, proficiency

Education, Experience & Licensing Requirements

• BA/BS in life sciences or related field or equivalent experience.
• 7+ years of relevant experience in a CDMO and/or pharmaceutical environment, preferably in Quality Assurance.

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.

Environment and Protective Equipment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

LIMITATIONS AND DISCLAIMER
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees. This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.