Specialist III, QA Investigations

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 root cause of atypical event and CAPA.
• Makes recommendations.

Conducts meetings to discuss findings and obtain resolution/commitments from customers to ensure agreement on investigation findings and appropriate CAPA has been identified with appropriate department.

• Schedules meetings with appropriate personnel

Emails investigation form to possible involved personnel to ensure all required people are involved.

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. Appropriate CAPA will help eliminate/minimize recurrence of atypical events.

• Sets up meeting with all affected departments.
• Determine 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
• Makes phone calls, participates in meetings, writes emails

Coaches and trains others on basic quality investigations for procedures and basic regulations to ensure all parties involved understand why we have to do what we do

• Conducts peer-reviews of other investigators' work; Answers any questions and directs investigators

Writes/revises Quality Assurance Departmental Procedures (DP's), Standard Operating Procedures (SOP's) 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.

Acts as a Quality representative for Company teams and when the Company plans major Quality-associated changes to ensure compliance with Food and Drug Administration (FDA) and Good Manufacturing Practices (GMP) requirements.

• Attends meetings and provides input.

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.
• Makes phone calls, participates in meetings, writes emails.

Other duties as assigned

Skills

• Competence in regulatory compliance and quality assurance
• Excellent 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.
• Possibility to travel
• Attention to detail/quality mindset.

Qualifications - Education and Experience

• Minimum Education: Bachelor's Degree, preferably in a scientific discipline
• Minimum Experience: 5-7 years of pharmaceutical experience or in a highly regulated industry;
• Preferred Experience: 3-5 years of experience in a cGMP lab

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.

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