About the Role
This role is responsible for executing quality control procedures, supporting technical investigations, and maintaining compliance within a regulated pharmaceutical setting.
Compensation
Competitive salary and benefits package offered
Work Arrangement
On-site position with potential for hybrid flexibility
Team
Part of a dedicated technical operations group focused on quality assurance
Responsibilities
- Perform analytical testing on raw materials, in-process samples, and finished products
- Follow established protocols for laboratory procedures and documentation
- Support method validation and transfer activities
- Investigate out-of-specification results and contribute to root cause analysis
- Maintain accurate records in compliance with Good Manufacturing Practices
- Operate and calibrate laboratory instrumentation as required
- Collaborate with cross-functional teams to resolve technical issues
- Ensure adherence to safety and quality standards at all times
- Participate in audits and regulatory inspections
- Contribute to continuous improvement initiatives within the lab
- Review test data for accuracy and completeness
- Assist in writing and revising standard operating procedures
- Support laboratory deviations and change control processes
- Monitor environmental conditions in controlled areas
- Handle samples according to defined handling and storage guidelines
- Track and report quality metrics to supervisory staff
- Engage in troubleshooting of analytical methods
- Maintain laboratory supplies and organize workspaces
- Stay current with industry regulations and technological advancements
- Participate in training programs to maintain technical competency
Qualifications
- Bachelor's degree in life sciences, chemistry, or related technical field
- Minimum of three years of experience in a laboratory or quality control setting
- Familiarity with cGMP and regulatory requirements in pharmaceuticals
- Proven ability to follow complex technical procedures
- Strong attention to detail and commitment to data integrity
- Experience with analytical techniques such as HPLC, GC, or spectrophotometry
- Proficiency in using laboratory information management systems
- Solid understanding of scientific documentation practices
- Ability to work effectively in a team-oriented environment
- Effective communication skills, both written and verbal
- Problem-solving aptitude in technical and operational contexts
- Willingness to adhere to strict safety and compliance protocols
- Experience with deviation investigations and CAPA systems
- Knowledge of statistical analysis tools used in quality control
- Comfort working in controlled laboratory environments
- Capacity to manage multiple tasks under tight timelines
- History of reliable attendance and professional conduct
- Adaptability to changing priorities and workflows
- Basic computer skills including word processing and spreadsheets
- Ability to lift and handle laboratory materials as needed
Preferred Qualifications
- Experience in a biotechnology or pharmaceutical manufacturing setting
- Prior work with biological therapeutics or large molecule assays
- Familiarity with automated laboratory equipment
- Training in laboratory safety standards and procedures
- Exposure to quality systems such as LIMS or TrackWise
- Background in microbiology or cell-based testing methods
- Participation in process improvement projects
- Certification in laboratory or quality disciplines
- Experience interpreting regulatory guidelines from FDA or EMA
- Demonstrated ability to work independently with minimal supervision
May offer sponsorship for qualified candidates
