Quality Control Analyst II
Job Purpose
Reporting to the QC Manager, the QC Analyst II will support and enhance quality control practices while promoting a culture compliant with cGMP, cGLP and Health & Safety standards within a pharmaceutical laboratory environment. The role involves performing routine and non-routine laboratory testing, conducting equipment maintenance as required, and carrying out sample testing of raw materials, in-process materials, finished products, and stability samples in accordance with approved standard operating procedures.
The QC Analyst II will revise and update standard operating procedures as necessary and may participate in special projects related to analytical methods and instrument troubleshooting. The role also includes contributing to investigations and preparing summaries and technical reports. The successful candidate must demonstrate strong knowledge and understanding of analytical chemistry principles and laboratory instrumentation.
Key Responsibilities
- Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, FDA/CVM, HS&E, etc.).
- Undertake the analysis of raw materials, intermediate bulks, and finished products, and stability of solid and liquid dosage forms.
- Initiate Laboratory Investigation Reports (LIRs), Out of Specification, Deviations, Change Controls, for related work.
- Exhibit detail-oriented documentation skills to ensure Right-First-Time testing.
- Identify and support resolution of technical problems.
- Receive and provide training to other analysts.
- Actively participate in group and project teamwork, project, and process improvement.
- Assist in preparing for internal and external inspections by ensuring Laboratory is always inspection ready.
- Ability to create/revise lab associated documents e.g. testing procedures, FNs, SOPs.
- Ensure lab cleanliness and safety standards are maintained.
- Conduct daily calibration/verification of laboratory equipment such as analytical balance.
- Support the team by performing tasks which include but are not limited to glassware washing, pipet washing, scanning documents, trending data, etc.
- Support other laboratory activities as directed by laboratory manager.
- In addition to the core responsibilities listed above, the jobholder may be required to perform other duties on an ad-hoc basis.
Key Performance Indicators
- Local and departmental metrics are effectively managed and in control.
- Responsibilities and accountabilities are fulfilled.
- Behaviours are in line with the Dechra Values.
- Delivery of personal and departmental objectives.
- Schedule Adherence
- QMS OTP
Our Ideal Candidate:
- Motivated and self-driven
- Strong coaching and mentoring skills
- Quality-conscious and customer-oriented
- Proactive and results-oriented
- Champion of GLP and GMP standards
- Accurate, precise, and able to work independently
- Strong attention to detail
- Strong teamwork and collaboration skills
- Effective communication skills with the ability to tailor messaging to different audiences
- Knowledge of and commitment to regulatory compliance
- Strong problem-solving and analytical abilities
- Pragmatic approach to decision-making with a focus on execution
Skills and Experience:
- Required: Bachelor's degree in a scientific discipline such as Pharmaceutical Sciences, Pharmacy, Chemistry, Biology, or a related field.
- Minimum of 2 years of experience working in a pharmaceutical GMP environment.
- Preferred: 5 years of experience working in a pharmaceutical GMP environment.
- Knowledge of GMP regulations applicable to products manufactured, tested, and marketed within the United States.
- Familiarity with environmental, health & safety (EHS), regulatory, and company standards.
- Experience working in a GMP laboratory environment.
- Experience with HPLC and/or GC in a GMP laboratory environment.
- Preferred: SME-level expertise in HPLC and GC methodologies.
- Familiarity with the United States Pharmacopeia (USP).
- Familiarity with raw material testing.
- Strong problem-solving skills and a collaborative, cross-functional mindset.
- Proactive approach to working across teams and supporting business objectives.
- Proficiency in Microsoft Excel.
- Strong computer literacy with exceptional attention to detail, including documentation accuracy, formatting, and data integrity.