QA Specialist II

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 QA Specialist II supports the Quality Management System (QMS) and the Document Management System (DMS) in a GMP regulated environment according to established operating procedures. The QMS and DMS functional areas include but are not limited to: Document Control, Training, Deviations, Out of Specification Investigations, Corrective and Preventive Actions (CAPA), Change Control, Complaints, Quality review of analytical and microbiological data and batch production records, Internal/external audits, supplier/subcontractor management, validation, and calibration & maintenance.

This role may participate in various aspects of technical data and documentation evaluation and review, manufacturing operations, laboratory operations, investigations, and a variety of routine and non-routine tasks. This role ensures that all QA activities are in compliance with company SOPs, GMP/GLP standards and client requirements. Ability to work within a dynamic and fast paced environment.

Responsibilities

• Responsible for performing an independent quality evaluation and release of support documentation, materials, products, equipment, and/or facilities. • Ensure all testing/manufacturing was performed per approved SOPs/methods/protocols and comply with specifications by critically evaluating the reported data and results for accuracy and compliance with other regulatory guidelines. • Works independently on problems of basic to moderately complex scope in which analysis of situation or data requires a review of identifiable factors. • Participates in department/client meetings, collaborates, and cooperates to achieve cross-functional improvements and business goals. • Ability to participate in internal, client and/or regulatory audits. Works with the site management in all areas to maintain a cGMP compliant facility in a constant state of inspection readiness. • Basic understanding of root cause analysis tools, CAPA and able to support quality events. • Good interpersonal skills and willing to ask questions about procedures and concepts. • Participates in the development, implementation, and maintenance of procedures and policies to comply with FDA, EU, and ICH requirements applicable to site’s needs. • Able to be trained and train/ mentor others. • Effectively resolves quality issues and concerns in a timely manner. • Effectively coordinates and organizes tasks to help drive the activities of the department; while performing a variety of duties on schedule, with accuracy and competency. • Creates strong and effective working relationships with Quality team, colleagues, and clients.

Qualifications/Skills

• Strong attention to detail, as well as time and resource management.

• Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to independently with minimal direction

• Promote a safe environment for work

• Communicate clearly and effectively both orally and in writing with internal and external clients.

• Working knowledge and understanding of LIMS and Empower.

• Skilled in MasterControl, Trackwise and/or other QMS software applications.

• Understanding of validation, production equipment, utilities, and/or drug development/manufacturing operations.

• Theoretical understanding and providing effective evaluation of laboratory practices such as raw material, drug substance, drug product and medical device testing, compendia methods (e.g. USP/NF, EP, JP), and method validation/qualification/transfer, as required.

Skills / Abilities:

• Demonstrate the capability for continued upward growth and technical contributions.

• Good analytical and problem-solving skills with proven ability to think strategically.

• Good understanding of current FDA, EU and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry

• Effective team and interpersonal skills with the ability to work across numerous scientific and management disciplines.

• Good diplomatic, analytical, and communication skills – both verbal and written.

• Good Computer Skills

• Microsoft Suite, proficiency

Education, Experience & Licensing Requirements

• Related BA/BS, required. • 2-4 years of relevant experience in a CDMO and/or pharmaceutical environment, preferably in Quality Assurance. • Experience in manufacturing operations, laboratory operations and/or QA, preferably in pharma or biotech.

Supervision Received: General SupervisionExercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments. May seek management direction for problems of diverse and/or complex scope.

Travel: Not Applicable

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, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 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.

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.

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.