Sr. QA Specialist II

Cambrex • Longmont, CO

2d

About The Position

The QA Specialist II supports the Quality Management System (QMS) and Document Management System (DMS) in a GMP-regulated environment, following established operating procedures. These functional areas include document control, training, deviations, out-of-specification investigations, CAPA, change control, complaints, quality review of analytical and microbiological data and batch production records, internal and external audits, supplier and subcontractor management, validation, and calibration and maintenance.

The role may involve evaluating and reviewing technical data and documentation, participating in manufacturing and laboratory operations and investigations, and completing routine and non-routine tasks. The position ensures QA activities comply with company SOPs, GMP/GLP standards, and client requirements, and requires working in a dynamic, fast-paced environment. The employee works under general supervision, exercises independent judgment in developing methods and evaluation criteria, and determines methods and procedures for new assignments, seeking management direction for problems of diverse or complex scope.

Requirements

• Related BA/BS degree.
• 2–4 years of relevant experience in a CDMO and/or pharmaceutical environment.
• Strong attention to detail and time and resource management.
• Integrity, trustworthiness, strong work ethics, and ability to work independently with minimal direction.
• Ability to promote a safe work environment.
• Clear and effective oral and written communication with internal and external clients.
• Working knowledge of LIMS and Empower.
• Good computer skills, including proficiency with Microsoft Suite.
• Good analytical and problem-solving skills and ability to think strategically.
• Understanding of current FDA, EU, and ICH requirements and their implementation for GLP and GMP in the pharmaceutical industry.
• Effective teamwork and interpersonal skills, including the ability to work across scientific and management disciplines.
• Diplomatic, analytical, and communication skills, both verbal and written.
• Ability to demonstrate continued upward growth and technical contributions.

Nice To Haves

• Relevant experience in Quality Assurance.
• Experience in manufacturing operations, laboratory operations, and/or QA, preferably in pharma or biotech.
• Skill with MasterControl, Trackwise, and/or other QMS software applications.
• Understanding of validation, production equipment, utilities, and/or drug development or manufacturing operations.
• Theoretical understanding and effective evaluation of laboratory practices, including raw material, drug substance, drug product, and medical device testing; compendial methods such as USP/NF, EP, and JP; and method validation, qualification, and transfer, as required.

Responsibilities

• Perform independent quality evaluations and release support documentation, materials, products, equipment, and/or facilities.
• Verify that testing and manufacturing were performed according to approved SOPs, methods, and protocols, and evaluate reported data and results for accuracy, specification compliance, and compliance with applicable regulatory guidelines.
• Work independently on problems of basic to moderately complex scope by reviewing identifiable factors.
• Participate in department and client meetings and collaborate across functions to support improvements and business goals.
• Participate in internal, client, and/or regulatory audits and work with site management to maintain a cGMP-compliant facility in a constant state of inspection readiness.
• Apply a basic understanding of root cause analysis tools and CAPA, and support quality events.
• Participate in developing, implementing, and maintaining procedures and policies to meet applicable FDA, EU, and ICH requirements.
• Train and mentor others as able.
• Resolve quality issues and concerns in a timely manner.
• Coordinate and organize departmental tasks, completing varied duties accurately, competently, and on schedule.
• Build effective working relationships with the Quality team, colleagues, and clients.

Benefits

• Medical, prescription, dental, and vision coverage.
• HSA and FSA options.
• 401(k) retirement savings plan with employer match.
• Paid time off.
• Paid sick leave.
• Employer-paid life and disability coverage.
• Paid parental leave after one year of service.
• Wellness and emotional support programs.
• Eligible for a 4% annual target bonus.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level