Manufacturing Compliance Specialist

KBI Biopharma•Durham, NC

About The Position

The Manufacturing Compliance Specialist supports the rapidly expanding GMP Contract Manufacturing Operation. The Specialist will need to produce high-quality documentation that contributes to the overall success of our operations. Independently responsible for the efficient and thorough investigation of process deviations (that occur in manufacturing; Upstream, Downstream and/or Support), determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the Quality related deficiencies identified during the investigation process. Responsible to provide proactive corrections based on noted trends to minimize the potential for repeat incidents. The position requires working with minimal supervision to manage assigned investigations from initiation to completion. The Specialist should have some experience in biotechnology manufacturing and quality system writing.

Requirements

BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience.
3-5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices including: QA, QC, Validation, Manufacturing, or process engineering.
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.
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.
Knowledge or / experience using Word, Excel, E-mail, Spreadsheets, ETQ
Knowledge or / experience using a computer, a telephone, a copy machine, and a fax machine

Responsibilities

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 Specialist 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.
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.

Benefits

KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching, and employee recognition programs.

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