(CW) QC Analyst Contract
About The Position
The Quality Control Analytical In-Process (QCA-IP) Analyst performs analytical test methods on in-process intermediates and drug products at varying stages, under minimal supervision and within cGMP guidelines, to support the manufacture of commercial and clinical therapeutics. The role involves analytical methods and concepts including protein determination by A280, Bradford and UV absorbance, enzyme activity, HPLC/UPLC, and method validation. The analyst performs a range of laboratory assays, manages sample throughput and laboratory supplies, prepares reagents, contributes to process and method validation, supports investigations and equipment validation, and proposes improvements to procedures. Work varies in complexity. The role requires following SOPs, making appropriate routine decisions, recognizing deviations, completing work accurately and on time, interpreting results against criteria, and applying critical thinking to routine work. The analyst also evaluates results against trend reports, helps troubleshoot and train others, follows up on atypical results and issues, communicates relevant information, and participates in team meetings. This is a contract role. The stated schedule is Wednesday through Saturday, onsite four days per week, on the swing shift from 1 p.m. to 11:30 p.m. The role also requires flexibility and willingness to work additional hours when needed to meet production or laboratory process requirements.
Requirements
- Bachelor of Science degree.
- 0–3 years of relevant laboratory experience; QC-specific experience is preferred.
- Experience with quality management systems, current Good Manufacturing Practices, and QC principles.
- Demonstrated working knowledge of certified functional activities.
- Good documentation skills and written and verbal communication skills.
- Ability to perform most tasks with minimal supervision.
- Computer literacy, including proficiency in Microsoft Word and Excel.
- Quality service attitude and focus, flexibility, and willingness to work additional hours to meet production or laboratory process requirements.
Nice To Haves
- QC-specific laboratory experience.
- Experience with Microsoft PowerPoint.
- Familiarity with BINOCS or similar scheduling systems.
- Familiarity with SAP or similar enterprise systems.
Responsibilities
- Facilitate timely receipt and accessioning of incoming samples and assign batches across assay types in accordance with agreed best practices.
- Execute analytical methods for in-process testing under applicable cGMP guidelines and report results promptly to meet internal customer timelines.
- Evaluate assay validity, calculate and summarize results, analyze data against expected or specification ranges, and assist in compiling and verifying trend analysis reports.
- Share laboratory housekeeping assignments with coworkers and maintain systems that support inspection readiness.
- Monitor and control laboratory supply and critical reagent inventories.
- Qualify as a trainer for specified methods and train less experienced staff.
- Communicate proactively about compliance risks and procedural deviations, and initiate investigation records within required timeframes.
- Provide input or assay support for test method validation, investigations, technical studies, and method transfer protocols.
- Attend team huddles and department meetings, and generate ideas for laboratory infrastructure improvements and method optimization.
- Identify opportunities to reduce non-value-added activities and increase process efficiency.
- Perform other responsibilities as necessary.
- Support environmental protection, injury prevention, and continual improvement of EHS management systems by identifying hazards, reporting incidents, and participating in EHS initiatives and training.
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What This Job Offers
Career Level
Entry Level
