Quality Compliance Specialist
Social Circle, Georgia
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Summary of Primary Duties:
Responsible for executing the various quality systems and business practices which enable positive outcomes of Health Authority (HA) inspections, as well as other external and internal audits. Responsible for the ownership and/or execution of the various processes and systems related to the Quality Compliance function at the Covington Manufacturing Facility including, but not limited to: inspection readiness, inspection management, product complaint management, risk management, and quality incident escalations. The role will entail identifying and implementing continuous improvement initiatives related to the site’s Quality Systems.
This position will serve as either a ready room coordinator, inspection liaison, and/or inspection host during inspections. The role will include being an independent internal auditor to perform site self inspections. This position is also responsible for leading various projects internal and/or external to the department. The level is also responsible for collaborating within the network to share inspection knowledge and drive process improvements at the site and global level. This level is expected to demonstrate skills as a subject matter expert during internal and external inspections.
Responsible for maintaining the site compliance program including GMP/Compliance walkthroughs, gap assessments, and delivery of continued education on GMP and Compliance; the handling of product complaints including timely closure of associated records; and the preparation and maintenance of key quality indicators and site metrics for the appropriate communication to Site Leadership and Global teams.
Supervision and guidance are mainly required to clarify directions; this level is capable of determining their own priorities and working with area and senior management to eliminate roadblocks.
- Interface with manufacturing, quality, and other support groups to promote adherence as well as resolve issues related to GMP and Compliance. Provide innovative solutions and drive continuous improvement initiatives related to various site processes.
- Maintain a high level of expertise in current regulatory requirements and serve as a plant resource for compliance to these requirements.
- Lead and/or facilitate the observation response process as per applicable procedures and to ensure the prevention of repeat observations.
- Lead “Audit Ready – All the Time” efforts for assigned areas and assist other areas within the facility in understanding FDA, EMA, ISO, and other quality requirements.
- Lead and/or conduct GMP/Compliance walkthroughs to identify potential gaps or risks and provide guidance on mitigation/resolution.
- Maintain inspection readiness plan; conduct inspection readiness and management training; and coordinate inspection support staff.
- Monitor ICAMS, QRAMS, and GCMS records for adherence to Global requirements. Identify potential concerns and recommend when escalation is needed.
- Lead and/or execute the product complaint handling process including completion of complaint evaluations and associated investigations.
- Lead and/or facilitate the gap assessment process and maintain the site risk register.
- Lead and/or actively participate in Quality Systems operating mechanisms at defined frequencies (e.g. Quality Council meeting, KPI meeting, Site Complaint Review meeting, etc.)
- Compile and/or review various key quality indicator trends/metric data at defined frequencies. Prepares and reports trend and metric data via management review operating mechanisms.
- Support activities related to Quality Incident Escalations, and escalation meetings as applicable.
- Author, assess, and/or approve inspection, complaint, deviation, and change records as needed.
- Represent the Quality Compliance department in network meetings as applicable.
- Provide guidance and coaching for areas of responsibility to less experienced individuals within the plant.
- Complete other tasks as assigned by management.
Education and Experience Requirements:
- Typically requires bachelor's degree in science, engineering, or other related technical field with 5+ years of related experience.
- Prefer experience with supporting HA inspections, e.g FDA, EMA, other MoHs
- Prefer experience with Product Complaint Management
Key Skills, Abilities, and Competencies:
- Strong knowledge of regulatory regulations, cGMP, and Quality Systems is required.
- Strong problem-solving and analytical skills are required.
- Possess knowledge of core manufacturing principles and support systems.
- Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.
- Possess good interpersonal/communication/influencing/negotiation skills.
- Be a self-driven individual who requires minimal supervision.
- Possess proficient computer skills and be experienced using MS Office software (Word, Excel, and PowerPoint).
- Possess good project management skills.
- Prefer experience with the TrackWise quality system.
- Prefer knowledge of Lean/Six-Sigma methodology.
Other Job Requirements:
Physical Demands -
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility
- Must be able to lift, push, pull and carry up to 20 lbs. In general, the position requires a combination of sedentary work and walking around observing conditions in the facility
Working Environment -
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body.
- No make-up, jewelry, nail polish, or artificial fingernails, etc. may be worn in the manufacturing environment.
- Will work in a cold, wet environment
- Requires flexibility to complete activities during off shift hours and/or conduct activities in support of different shifts as needed.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Job ID SR0049977