Investigation Specialist-Quality

Job Description

The Investigation Specialist will work cross-functionally with 503A and 503B operations and perform investigations keeping holistic view in mind. The specialist is responsible for driving the resolution of product quality related issues by gathering and analyzing relevant information, determining the accurate cause and defining appropriate corrective/preventive actions to prevent recurrence meeting regulatory (FDA, DEA, Boards of Pharmacy) expectations. The specialist will ensure CAPA effectiveness and lead QMS communication within the organization.

This is an on-site position in Ocala, FL. This position will support our FL, TN and Dallas, TX operations.

Essential Functions

• Perform investigations independently to assess aberrant events impacting product quality that could prevent product release. Performs interviews and schedule follow-up meetings in response to investigations.
• Perform gap assessments and root cause analysis evaluations to determine RISK level utilizing root cause analysis tools such as FMEA, wishbone and/or 5 Why tools.
• Ensure root cause analyses, CAPA effectiveness checks and risk analysis for products, processes and systems
• Review EM, sterility, potency test results, specifications, batch records, qualification/validation protocols and reports and SOPs and write investigation reports
• Directly support the business through schedule/timeline adherence for batch releases of commercial products.
• Recommend quality process improvements to increase efficiencies and performance of systems, operations and personnel and prevent reoccurrence of incident or event.
• Write investigation reports in a clear and concise manner to withstand regulatory scrutiny, with sufficient detail to support decisions drawn and actions taken to resolve an event.
• Identify and resolve objectionable GMP issues which may impact product quality and escalate the issues.
• Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as GMP and health and safety requirements in the markets where product is sold.
• Use technical, scientific and professional judgment for assessing the effectiveness of CAPAs, strengthen systems and communicate with cross-functional team within the WPN organization

Education and Experience:

• Bachelor Degree (BA/BS) in Science (Chemistry, Microbiology or Biology) or Engineering, Quality Management or related field – (Required)
• 3 – 5 years of hands on experience in QA, QC or Operations environment
• Experience with microbiology, and QMS components including OOS, OOT, Incidents deviation, CAPA, Product market complaints
• Demonstrated “change agent” skills; inclusive of influence management, project management, vision development, and people motivation skills.
• Effective communication (both written and verbally), interpersonal and organization skills.
• Must be results-oriented, able to make decisions independently, and able to prioritize work per business needs
• Strong knowledge of GMPs and FDA, DEA, BoP regulatory requirements

Job Type: Full-time

Pay: From $60,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 3 years

Schedule:

• Monday to Friday
• Weekends as needed

Work setting:

• In-person
• Office

Application Question(s):

• Do you havea Bachelors Degree (BA/BS) in Science (Chemistry, Microbiology or Biology) or Engineering, Quality Management or related field? – (Required)
• Do you have 3 – 5 years of hands on experience in QA, QC or Operations environment?
• Do you have experience with microbiology, and QMS components including OOS, OOT, Incidents deviation, CAPA, Product market complaints?
• Do you have demonstrated “change agent” skills; inclusive of influence management, project management, vision development, and people motivation skills?
• Do you have effective communication (both written and verbally), interpersonal and organization skills?
• Are you results-oriented, able to make decisions independently, and able to prioritize work per business needs?
• Do you have strong knowledge of GMPs and FDA, DEA, BoP regulatory requirements?
• Do you have experience in Quality?

Ability to Relocate:

• Ocala, FL 34474: Relocate before starting work (Required)

Work Location: In person

Salary : $60,000