Sr. QC Analyst

Germer International; Bethlehem (Northampton County); On-site; USD 65,000 - 90,000; Full time

Job summary

Germer International is seeking a QC Data Integrity & Compliance Specialist to monitor electronic systems, support audits, and ensure cGMP/GDP documentation. You will perform analytical testing on in-process materials, raw materials, and finished products, while maintaining data integrity and preparing quality metrics.

The role emphasizes training, collaboration with auditors, and adherence to regulatory standards to support inspection readiness across QC activities.

Qualifications

• Bachelor's or Associate degree in science.
• 　
• 3+ years of QC lab experience.
• Knowledge of data integrity and electronic compliance.
• Experience with audits/inspections preferred.
• Familiarity with cGMP, quality and safety norms in regulated industry.
• Experience with SAP, LabX, TrackWise, CaliberLIMS preferred.

Responsibilities

• Monitor QC compliance with electronic systems and laboratory applications.
• Support audit readiness and review electronic records and audit trails.
• Assist in responses to audit observations and information requests.
• Serve as a QC Data Integrity and Compliance Champion.
• Perform analytical testing of in-process materials, API, and finished products.
• Document work per cGMP and GDP.
• Maintain data integrity and regulatory compliance.
• Coordinate training and onboarding for new hires as required.

Skills

Data integrity

Audit readiness

Analytical testing

Laboratory systems

Regulatory compliance

Electronic records

Documentation

Communication

Training & coaching

Problem solving

Education

Bachelor's or Associate degree in science

Tools

SAP

MS Office

Ensur

Openlab

LabX

TrackWise

CaliberLIMS

Job description

Essential Duties and Responsibilities

• Monitor and support QC compliance with electronic systems and computerized laboratory applications.
• Support periodic review of electronic records and audit trails.
• Support inspection and audit readiness activities within QC.
• Participate in internal, customer, and regulatory audits/inspections.
• Assist in the preparation, review, and timely submission of responses to audit observations and requests for information.
• Serve as a QC Data Integrity and Compliance (DICO) Champion.
• Perform analytical testing of in-process material, bulk drug substance, finished drug product, stability samples, and raw materials
• Sampling, inspection and testing of packaging components upon receipt
• Proper documentation of all work according to cGMP and GDP
• Understand and applies the 21 CFR Part 11 requirements
• Maintains data integrity and compliance with regulatory standards
• Responsible for sampling of bulk API and bulk drums (API and raw material) for analysis by QC
• Prepare Quality Metrics for in-process, API, and FG turnaround times
• Perform calibration and minor troubleshooting on select laboratory instruments with appropriate training including GC, HPLC, UV/Vis, IR, Potentiometer, Refractometer, Karl Fischer, Density meter, Oven
• Perform validation of new lab instruments and equipment as required
• Perform daily general duties in a proper functioning QC lab like balance checks, glassware washing, gas cylinder changes, temperature record checks, inventory supplies including reference standards
• Assist other chemists in completing quality laboratory investigations in response to out of specification, out of trend, questionable results or in response to a lab deviation
• Manage and conduct investigations, as assigned and required, for laboratory events, change controls, CAPA, and deviations
• Oversee the training structure and conduct training for new hires as required
• Peer review of raw data of initial analysis to release material in a timely fashion
• Assist Lab Coordinator with stability put-ups or take-outs when necessary due to large volume of samples
• Assist QC Supervisor in the approval of stability packets in the required electronic system
• Able to create or review QC related documents as required

Key Competencies (knowledge, skills and abilities every person must possess to be successful)

• Critical Thinking — using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems
• Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers
• Ability to serve as a QC Data Integrity and Compliance (DICO) Champion and promote a strong culture of data integrity, electronic compliance, and inspection readiness.
• Ability to interpret analytical data, identify trends, prepare quality metrics, and communicate findings effectively.
• Knowledge and practical understanding of electronic laboratory systems and computerized systems, including audit trails, electronic records, electronic signatures, user access, and system-generated data.
• Strong audit and inspection readiness mindset, with the ability to organize and provide accurate laboratory documentation and supporting information in response to internal, customer, and regulatory audits/inspections.
• Excellent verbal and written communication skills
• Creative and able to present various solutions
• Energetic, enthusiastic, and motivational disposition
• Maintain confidentiality
• Coaching skills

Education / Experience

• Bachelor’s degree or Associate’s degree in science
• 3+ plus years of experience in a QC lab environment
• Understand chemical processes and reactions
• Prior experience with data integrity, electronic compliance, computerized laboratory systems, or serving as a quality/data integrity champion is preferred
• Experience supporting internal, customer, or regulatory audits/inspections preferred.
• Awareness of cGMP, quality and safety norms and requirements in a regulated industry
• Usage of technology tools such as SAP, MS office, Ensur, Openlab, LabX, TrackWise, CaliberLIMS is preferred.
• Experience with quality metrics, laboratory performance monitoring, and trend analysis preferred.