Senior Quality Control Analyst - Biochemistry (Raw Materials)
To support laboratory projects activities, conduct biological, chemical and physical analyses by using sophisticated laboratory instrumentation and computer systems to collect and record data. To be familiar with analytical, biological, chemical and Lean principles, GDP, cGMP, SOPs, FDA, and QSR regulations. Contribute to a team setting within the laboratory and or other departmental personnel to increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.
Essential Duties and Responsibilities
- Support laboratory projects activities: conduct biological, chemical and physical analyses on test samples following procedures; help prepare and complete technical documentation. Work under minimal Supervision
- Use sophisticated laboratory instrumentation and computer systems to collect and record data. Perform advanced assays requiring precise analytical skills and understanding of biological and chemical principles.
- Perform review and evaluation of test data with application of GDP and GLP.
- Complete special project/protocol testing in a timely manner under direction of Project Leads and/or Supervisor
- Prepare lab protocol studies/validations with some supervision
- Familiarity with code of federal regulations, and compendia requirements.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, QSR, and cGMP regulations
- Use Global LIMS or other computerized systems for entering and approving test results as applicable
- Contribute to a team setting within the laboratory and project activities and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support
- Ensure area is maintained in a GMP state at all times while following all EHS and 5S guidelines
- Prepare and update CTPs and SOPs as required under supervision
- Perform equipment maintenance and calibrations as required
- Apply Lean principles such as 5S throughout daily work activities
- Ensure personal training requirements are met and that training records are current. Train staff per project needs.
- Perform Disposal of Hazardous Waste (as applicable).
- Effective in handling multiple tasks concurrently and complete tasks in a timely manner
- Effective organizational skills and ability to plan and suggest resolutions to technical or resource problems.
- Proficient in advanced wet and instrumental methods of analyses.
- Demonstrated technical knowledge and experience in assays/equipment in functional area
- Proficient with lab application software and able to learn new computer systems and programs in a timely manner.
- Effective decision-making skills to problem-solve technical, compliance, or operational problems
- Computer literate and competent with a general knowledge of word processing and spreadsheets (such as Microsoft Office and Minitab)
- Must be detail oriented, conscientious and have a high reading comprehension skill
- Proficient understanding of laboratory instrumentation and chemical handling
- Effective interpersonal communication and influencing skills. Must have effective verbal and written communication skills.Effective presentation skills a plus
- Must be able to understand and apply cGMP/DPD, follow CTP/SOPs, and meet EHS requirements.
Education and/or Experience
- Typically requires bachelor's degree in chemistry, biological science, or other related technical field. 2+ years of related experience.
- Must be able to lift, push, pull and carry up to 25 lbs.
- 20/20 near vision required (corrected as acceptable) – as applicable for project.
- No contact lenses may be worn in the work environment.No make-up, jewelry, nail polish or artificial nails may be worn in the work environment when applicable.
- In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility.
- May be required to enter a cold, wet environment and climb stairs or ladders to retrieve samples.
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
- Must be able to work multiple shifts, including weekends.
- Must be able to work overtime as required (APPLICABLE TO SNE only).
- May be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.