EDUCATION:
* B.S or B.A in a technical discipline, preferably Microbiology, Biology/Virology, Biochemistry, Chemistry, Engineering or Pharmacy. Degree in other discipline if sufficient technical depth has been achieved from professional experience.
Qualifications and Skills
Education:
- Bachelor's degree in a technical field, such as Microbiology, Biology, Biochemistry, Chemistry, Engineering, or Pharmacy. Equivalent experience with sufficient technical depth will also be considered.
Experience:
- Minimum of 3 years' experience in pharmaceutical manufacturing or quality assurance, focusing on deviation investigations.
Technical Skills:
- Strong understanding of pharmaceutical facilities, equipment, and systems.
- Familiarity with GMPs, NIH guidelines, and FDA regulatory requirements.
- Proficiency in conducting root cause analyses and implementing corrective actions.
- Intermediate computer skills and the ability to manage technical documentation.
Soft Skills:
- Excellent verbal and written communication skills.
- Ability to work collaboratively in a matrix organization with cross-functional teams.
- Exceptional problem-solving and investigational abilities.
- Detail-oriented, highly organized, and capable of managing multiple priorities with minimal supervision.
- Demonstrates urgency, accountability, and integrity in all responsibilities.
* Working knowledge of pharmaceutical facilities, equipment and systems. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities.
* Demonstrated problem solving and investigational skills. Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance.
* The ability to communicate both verbally and in writing with all levels both inside and outside of the organization.
* The ability to clearly write technical documentation as necessitated by regulatory agencies and internal policy.
* Ability to establish and maintain working relationships with staff and the ability to analyze data and implement changes.
* Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA.
* Ability to work in a highly complex matrix environment.
* Able to prioritize and decide appropriate course of actions and to effectively implement decisions.
* Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions.
* Able to maintain attention to detail while executing multiple tasks.
* Able to perform job duties with minimal supervision.
* Must be able to address complex problems associated with assessing deviations, determination of root cause, and implementation of change and improvement to validated and/or FDA approved production systems.
* Must have an aptitude for facilitating a team environment and working independently toward the goal of completing product investigations.
* Must operate cross-functionally and be able to lead in a matrix organization.
* Sense of urgency, flexibility and accountability. Intermediate computer skills required.
* Stay current on developments in the field and company Standards.
* Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
* Maintain a high level of integrity while balancing multiple priorities and responsibilities.
Why Join Us?
By joining Alphanumeric, you'll contribute to meaningful work that improves lives while collaborating with a team of experts in a fast-paced, dynamic environment.