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Form of work1st Shift, Monday through Friday, 8am - 4:30pm
Job req: 3574
To ensure quality and compliance to regulations with respect to investigation of atypical events, i.e. Investigate and document atypical events - resulting in a recommendation of final disposition for goods, while identifying appropriate Corrective Action-Preventative Action (CAPA).
Responsibilities
Conducts investigations on atypical events and documents accordingly to meet a Code of Federal Regulations requirement:
Conducts meetings to discuss findings and obtain resolution/commitments from customers. Ensures agreement on investigation findings and appropriate CAPA has been identified with appropriate department.
Works directly with peer customers to resolve issues
Recommends corrective actions as part of the atypical events investigation and follows up/becomes involved with department to provide guidance
Makes recommendations with assistance of supervisor related to go/no-go decisions which impact production.
Coaches and trains others on basic quality investigations for procedures and basic regulations
Writes/revises Quality Assurance Departmental Procedures, Standard Operating Procedures, and documentation to ensure compliance to requirements and efficient standardize practices.
Communicates clearly to peers, customers, and supervision. Communication is key to identifying root cause of the atypical event and appropriate CAPA
Qualifications
What We Offer
*Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms.
Location:
Job req: 3574
To ensure quality and compliance to regulations with respect to investigation of atypical events, i.e. Investigate and document atypical events - resulting in a recommendation of final disposition for goods, while identifying appropriate Corrective Action-Preventative Action (CAPA).
Responsibilities
Conducts investigations on atypical events and documents accordingly to meet a Code of Federal Regulations requirement:
- Locates the batch record
- Interviews the people involved with the process in question
- Documents all facts in the investigation form
- Determine the root cause of atypical event and CAPA
- Makes recommendations
Conducts meetings to discuss findings and obtain resolution/commitments from customers. Ensures agreement on investigation findings and appropriate CAPA has been identified with appropriate department.
- Emails investigation form to possible involved personnel to ensure all required people are involved
- Schedules meetings with appropriate personnel
Works directly with peer customers to resolve issues
- Gather and document factual data that is used in written investigations to justify disposition of material
- Interviews employee and asks questions about incident report
Recommends corrective actions as part of the atypical events investigation and follows up/becomes involved with department to provide guidance
- Appropriate CAPA will help eliminate/minimize recurrence of atypical events
- Sets up meeting with all affected departments
- Determines appropriate CAPA
Makes recommendations with assistance of supervisor related to go/no-go decisions which impact production.
- Keeps production moving with timely responses. Consult with supervisor to ensure knowledge is passed on, up and down the chain.
- Assesses situation to determine if production should be continued or interrupted after an atypical event
- Contacts managers to ensure all information is passed up and down the chain
Coaches and trains others on basic quality investigations for procedures and basic regulations
- Ensure all parties involved understand why we have to do what we do
- Conducts peer reviews of others investigator's work
- Answers any questions and directs fellow investigators
Writes/revises Quality Assurance Departmental Procedures, Standard Operating Procedures, and documentation to ensure compliance to requirements and efficient standardize practices.
- Goes out on floor and researches step-by-step walkthrough of process
- Conducts mock implementation
- Recommends changes to procedures after investigations
Communicates clearly to peers, customers, and supervision. Communication is key to identifying root cause of the atypical event and appropriate CAPA
- Communication imperative so that all operating units understand impact of atypical event at all stages of the investigation
- Good verbal/written communication skills
- Planning/organization skills a must
- Flexibility to changing work environment and deliverables
- Standard business computer skills, word, excel, etc as required.
- Attention to detail/quality mindset
- Teamwork and collaboration
- Delivering Results
- Fast and focused execution
- Other duties as assigned
Qualifications
- High school diploma/GED with minimum of 3+ years pharmaceutical experience
- Bachelors Degree in scientific or engineering discipline with some relevant experience in a Quality function (preferred)
What We Offer
- Clean climate-controlled working environment
- Annual performance bonus potential
- 401k employer match, up to 6% of your contributions
- 23 paid time off/personal days (prorated based on hire date)
- 11 paid Company holidays
- Generous healthcare benefits
- Employee discount program
- Wellbeing rewards programs
- Safety and Quality is a top organizational priority
- Career advancement/growth opportunities
- Tuition Reimbursement
- Maternity and Parental Leave
*Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms.
Location:
