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12 days old

Senior Manufacturing Compliance Specialist - Investigations/Deviations

Kelly Services
Durham, NC 27722
**Senior Manufacturing Compliance Specialist Investigations/CAPAs**


**Durham, NC**


**Position Summary**


+ Represent the team in high level meetings and assume leader roles within the Manufacturing Compliance and Training Department.

+ In preparation for PAI readiness and in support of Audits tours, Lead and Coordinate the Manufacturing and Facilities Walkthrough Program. Identify a list of possible observations, update the Walkthrough Program Tracker and perform the corresponding follow up with area owners.

+ Lead, provide guidance and support to Manufacturing Compliance Specialist.

+ Provides training for investigative staff and aids in their professional development; explains existing policies and procedures.

+ Identifies issues and concerns from the investigations, leading to recommendations for review and improvement of policies, procedures, training and/or equipment.

+ Summarizes and explains progress and results of investigations to Management.

+ Lead, manage or participate in critical investigations. May represent Manufacturing Compliance and Training Management in meetings and other forums if needed.

+ Provide additional administrative support to Manufacturing Compliance and Training Management.

+ As part of each investigation, gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on manufactured product, as well as the risk to future operations.


+ The investigator will conduct and drive closure of non-conformance events to identify root cause, product impact and preventative actions for Manufacturing Operations in support of batch disposition and continuous process improvement. Work with internal teams to obtain an in-depth understanding of the product and the documentation requirements.


+ Properly assess the manufacturing or analytical environment and independently conceives and documents appropriate corrective/preventative actions designed to mitigate Quality deficiencies identified in the investigative process using analytical tools.

+ Analyze existing deviations and a potential deviation focusing on establishes effective corrective and preventive actions to minimize the reoccurrence of the event.

+ Produce high-quality documentation that meets applicable standards and is appropriate for its intended audience.

+ Complete investigations and CAPAs in alignment with established procedures and timelines.

+ Work across functions with a professional manner to conduct investigations and CAPAs.


+ Works independently to comply with procedure driven guidelines relating to Deviation investigations and CAPAs.

+ Demonstrates strong technical skills. Provides technical assistance to area supervisors or managers to solve complex problems. Exercises judgment in developing practices, techniques and evaluation criteria for obtaining results.


**Position Responsibility**


+ Assist immediate manager with achieving departmental requirements by meeting or exceeding productivity, quality and capacity objectives.

+ Gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on manufactured product, as well as the risk to future operations. Analyze existing and potential content, focusing on reuse and single-sourcing opportunities.

+ Produce high-quality documentation that meets applicable standards and is appropriate for its intended audience.

+ Demonstrates strong technical skills. Provides technical assistance to area supervisors or managers to solve complex problems. Exercises judgment in developing practices, techniques and evaluation criteria for obtaining results.

+ Work off-shift hours as necessary or assigned.


**Minimum Requirements**


+ BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience; more than 5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices including: QA, QC, Validation, Manufacturing, or process engineering.

+ Must have experience investigating and authoring deviation investigations and CAPAs in a pharmaceutical or biotechnology manufacturing environment

+ Must be able to interface positively with Regulatory Agencies, customers, and company departments.

+ Strong time management skills and an ability to multitask in a face paced environment.


+ Ability to read and interpret English documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records. Ability to write routine reports and correspondence. Ability to speak effectively before internal groups or employees of organization. Good deductive and inductive critical thinking skills required.

+ Advanced writing skills required.


+ Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Strong time management skills and an ability to multitask in a face paced environment. Ability to deliver high quality documentation paying attention to detail.

+ Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures.


+ Ability to add, subtracts, multiply, and divides in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-10-04 Expires: 2021-11-04

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Senior Manufacturing Compliance Specialist - Investigations/Deviations

Kelly Services
Durham, NC 27722

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