What are the responsibilities and job description for the QC Analyst II or III position at Precigen, Inc?
Precigen is seeking a hard-working QC Analyst II or III (level determined by candidate experience) who is serious about their discipline and wants to be a key player in a high-performing team. This position will require performing analytical testing for lot release and stability samples following approved SOP’s in a GMP compliant laboratory. Secondary responsibilities include analytical method development and qualification. The QC Analyst II/III will be responsible for ensuring that samples are collected, tested, and reviewed according to quality requirements and that results reported are valid, accurate, and documented per applicable regulatory and corporate requirements.
Upon hire to this position Precigen will require documentation of a COVID-19 vaccination or exemption for medical or religious reasons.
DUTIES AND RESPONSIBILITIES:
- Perform GMP release and stability testing in Quality Control including but not limited to: HPLC for biological samples, Spectrophotometry, pH, Conductivity, ELISA, Dynamic Light Scattering (DLS) and PCR/RT-PCR.
- Participate in analytical method development, qualification, validation and technology transfer.
- Write and revise QC SOP’s.
- Maintain and operate QC laboratory equipment in a cGMP-compliant manner.
- General maintenance of the laboratory including ordering and receiving QC materials.
- Apply critical thought to solving problems of complex scope.
- Prepare investigation reports, including those related to OOS, invalid assays and deviations
EDUCATION AND EXPERIENCE:
- Bachelor’s Degree in biological science or related field.
- Minimum of three (3) years’ experience working in a regulated QC laboratory for biological test samples or assay development.
- Demonstrated experience working with, or development, of SOPs.
- Knowledge in principles and practices of current Good Manufacturing Practices (cGMPs.)
- Experience with methods and systems used in a biological QC laboratory.
DESIRED KEY COMPETENCIES:
- Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.
- Self-motivated and willing to accept temporary responsibilities outside of initial job description and perform other responsibilities to support the needs of the department, as assigned.
- Positive interpersonal skills.
- Self-organizer, meticulous hands-on habits, keen attention to detail.
- Ability to manage multiple and varied tasks, and prioritize workload.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Proficient in MS-Word and MS-Excel.
- Strong quantitative and analytical skills.
- Ability to understand and execute on the company’s mission and values.
- Maintain a high degree of ethical standard and trustworthiness.
- Responsive, can-do attitude.
- Deals with conflict in a direct, positive manner.
- Ability to think and adapt to a rapidly changing environment and demands.
EOE MFDV
