Quality Engineer (Target24)

Overview

Quality Engineer (Target24) Jobs in Daleville, VA at Munters Corporation (MUS)

COMPANY OVERVIEW

· SpectronRx is a rapidly growing Contract Development and Manufacturing Organization (CDMO & CMO) based in Indianapolis, IN, with additional locations in South Bend and Bunker Hill, IN, Danbury, CT and Europe. We are seeking an experienced Associate Director, CMC QA/RA (Quality and Regulatory) to join our growing company. The Associate Director, CMC QA/RA will assist with oversight of various aspects of CMC related quality assurance and compliance. The Associate Director, CMC QA/RA will dual report to the Director of Technical Development & Transfers and SVP of Quality, Regulatory and Compliance.

ESSENTIAL FUNCTIONS

· Provide strong strategic leadership for CMC QA/RA at SpectronRx in support of Good Manufacturing Practices (GMPs) with significant operational, quality & regulatory experience.

· Provide independent oversight and compliance direction with authority for CMC Quality and product disposition, including CDMO’s & CMOs.

o Drive process and product quality through effective virtual CMC quality systems oversight/surveillance.

o Transfer documents from partners into SpectronRx templates and assist R&D team in SOP writing, as applicable.

o Review, Approve Protocols and Reports, Project SOPs and Executed Batch Records as applicable.

o Ensure that all necessary steps and results are added to the Technical Transfer Plan.

o Review and verify process data to assure compliance with data integrity and traceability regulatory requirements as appropriate.

o Ensure that SpectronRx and its partners are inspection-ready for health authority audits by regulatory agencies; lead engagements with health authorities.

· Assist in preparation and review of CMC regulatory filings (e.g., INDs, BLAs, Annual Reports); ensure compliance with regulatory procedures.

· Assist R&D team in troubleshooting manufacturing, chemistry and analytical testing areas of concerns.

· Oversee development and maintenance of internal/external manufacturing and operational SOPs related to GXP activities, with primary focus on cGMP regulations.

· Ensure that all products manufactured meet the registration and cGMP requirements based on global regulatory requirements.

· Responsible for driving efficiencies and supporting the overall manufacturing process including process development activities, drug substance formulation and drug product manufacturing.

· Utilize GMP-regulated quality management systems and eQMS, including document control, change control, deviations/complaints, DS/DP release and CAPAs.

· Coordinate with other departments within SpectronRx to establish a robust QMS process.

· Develop strategic plans using a Quality Systems approach to accommodate CMC department and Quality division growth.

· Provide direct oversight of activities related to participation in U.S. FDA and other regulatory agency inspections.

· Train and mentor junior staff; provide company-wide training as needed.

· Perform other quality-related responsibilities in support of the CMC QA/RA team, as necessary.

· Has the authority to edit, revise, and approve Standard Operating Procedures (SOP).

· Ensure that various quality assurance agreements are properly implemented, as applicable.

· Assist in oversight and management of the change control, deviation, and out-of-specification (OOS) processes in cooperation with Quality Management, business partners and any subcontractors.

· Ensure site is ready for FDA inspection. Directly participate on site in FDA inspections.

· As applicable, assist in the development and implementation of the response to audits; ensure audit items are effectively closed in a timely manner.

· Review documents associated with the QA program for completeness, errors, and omissions. Review of executed cGMP records and product batch records to ensure compliance and product quality.

· Review of trends such as environmental monitoring (EM), OOS, and CAPA to ensure appropriate corrective and preventive actions are taken and/or for continuous improvement, as applicable.

· Assist with any product complaints, EM excursions, sterility test issues, adverse event investigations, pharmacovigilance reporting, etc.

· Responds to and investigates quality and regulatory incidents and events, as necessary.

· Assists with FDA submissions and lifecycle management of regulatory submissions.

· Address Quality and Regulatory issues related to the introduction of a new drug.

· Performs other related duties as assigned.

KNOWLEDGE-SKILLS-ABILITIES

· Physical Ability – Prolonged periods sitting at a desk and working on a computer.

· Customer and Personal Service – Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.

· Active Listening – Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.

Speaking – Talking to others to convey information effectively.
Critical Thinking – Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
Time Management – Managing one’s own time and the time of others.
Active Learning – Understanding the implications of new information for both current and future problem-solving and decision-making.
Coordination – Adjusting actions in relation to others’ actions.
Oral Comprehension – The ability to listen to and understand information and ideas presented through spoken words and sentences.

· Oral Expression – The ability to communicate information and ideas in speaking so others will understand.

Written Comprehension – The ability to read and understand information and ideas presented in writing.
Written Expression – The ability to communicate information and ideas in writing so others will understand.

· Deductive Reasoning – The ability to apply general rules to specific problems to produce answers that make sense.

TRAVEL

Regular travel is minimal

REQUIRED EDUCATION AND EXPERIENCE

· Bachelor’s degree in a scientific field is required.

· Minimum of 10 years of experience in a cGMP/FDA-regulated environment is required.

· Experience and/or full knowledge of manufacturing operations and the preparation of sterile injectables is required.

· Knowledge of relevant USP and FDA regulations, as well as cGMP requirements, is required.

Exemplary Customer Service skills
Time Management skills
PC and Microsoft Office skills

· Thorough understanding of project management.

· Excellent organizational skills and attention to detail.

PREFERRED EDUCATION AND EXPERIENCE

· Radiopharmaceutical CMC experience is preferred

· Regulatory Affairs Certification (RAC) is a plus

· Knowledge of how and ability to write, review and revise SOPs is required.

· Ability to analyze and interpret technical procedures and governmental regulations.

Ability to train and be trained

ADDITIONAL REQUIREMENTS

Valid driver’s license
Pass a Background Check.

ADDITIONAL INFORMATION/BENEFITS

· Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

· We recognize that people come with a wealth of experience and talent beyond just the technical requirements of the job. If your experience is close to what you see listed here, please still consider applying. Diversity of experience and skills combined with passion is a key to innovation and excellence; therefore, we encourage people from all backgrounds to apply to our positions. Please let us know if you require accommodations during the interview process.

We are an equal opportunity employer. Qualified applicants shall be considered for all positions without regard to race, color, sex, religion, national origin, age, disability, veteran status, or any other status protected by federal, state or local law. Refusal to submit to testing will result in disqualification of further employment consideration.

Job Type: Full-time

Pay: $117,132.00 – $129,457.00 per year

Benefits:

401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance

Schedule:

10 hour shift
8 hour shift
Day shift
Holidays
Monday to Friday
Overtime

Education:

Bachelor’s (Required)

Experience:

GMP / FDA Regulated: 10 years (Required)
CMC: 3 years (Preferred)
Radiopharmaceutical: 3 years (Preferred)

Ability to Relocate:

Indianapolis, IN 46268: Relocate before starting work (Required)

Work Location: In person

Title: Quality Engineer (Target24)

Company: Munters Corporation (MUS)

Location: Daleville, VA