Supervisor, Manufacturing Quality Assurance (Midnight Shift)

Quality & Compliance Rochester, Michigan


Description

Supervisor, Manufacturing Quality Assurance, Quality Assurance Operations, Michigan-Rochester

 

About Endo International plc

Endo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA, employing approximately 3,000 people worldwide.  For 2018 Endo, reported revenue of $2.947B and adjusted diluted EPS of $2.89.  Learn more at www.endo.com.

 

POSITION SUMMARY:

The Supervisor, under limited management, ensures compliance with cGMP and company  policies/procedures/ specifications. Oversees Specialists, ensuring manufacturing ops conform to established procedures / regulatory requirements. Ensures timely completion of batch record reviews and audits manufacturing areas. Interfaces with Quality Management Systems including but not limited to TrackWise, Maximo and inventory mgt. Writes/evaluates/approves quality investigations, corrective and preventive actions (CAPA), SOPs, and protocols. Leads teams to develop/implement Continuous Improvement within dept and across site. Assist in troubleshooting manufacturing problems and inspection/packaging defects. Make improvements in cGMP standards, implement new quality initiatives; assist in reviewing/ approving cGMP documentation.

QA Mfg responsibilities for a single site.

 

ROLE AND RESPONSIBILITIES:

Quality Assurance Management

  • Performs on-line auditing in Inspection and Packaging (AQL checks) or Mfg when necessary.
  • Assists and supports Sterile Filling, Bulk Mfg, Inspection & Packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.
  • Assists MQA Specialists in solving compliance errors when detected during processes.
  • Participates in or leads Cross Functional Investigations as assigned by upper management.
  • Make effective decisions in a timely manner and be focused on execution until completion.
  • Recognizes problems within scope of job; promptly communicates to management.
  • Follows directions and demonstrates proper judgment when a deviation occurs.
  • Provides QA oversight in mfg ops to ensure product/facilities comply with SOPs/policies/cGMPs.
  • Participates in resolving deviations and implementing CAPA.
  • Independently manages simple to complex discrepancies.
  • Key Quality contact for manufacturing discrepancy mgt, batch review, and line support.
  • Performs assigned tasks and work to achieve company goals and department objectives.
  • Leads or participates in and provides leadership for projects as designated by upper mgmt.
  • Recognizes trends, deviations, problems and promptly reports them to management.
  • Schedules floor/area coverage to meet production needs.
  • Reviews and approves master batch records supporting commercial & clinical production as well as validation protocols and reports for equipment requalification or IQ/OQ/PQ.
  • Multitasks and manages competing priorities while meeting production timelines.
  • Represents Quality Assurance at meetings.

 

Documentation & SOPs

  • Reviews batch record documentation included but not limiting to bulk, sterile filling, inspection, packaging and components to ensure compliance with SOPs and policies.
  • Participates in development, authoring and/or review of SOPs/policies to support QA ops.

 

Compliance

  • Enforces quality standards and process controls.
  • Leads or responds to, quality audits when applicable to assure conformance with regulatory and internal requirements.  Has the skills necessary to conduct own internal audits.
  • Works in timely, safe manner conforming to regulatory, co. and compendial requirements.
  • Provides direct manufacturing QA support during internal/external regulatory inspections.

 

Staff Development

  • Supervises/trains QA staff at various levels, such as in-process, sampling, product release etc.
  • Monitors employee performance, provides feedback, conducts performance reviews, develop and administer enhancement plans, and follow-up on personnel issues where necessary.
  • Provides and designs group performance metrics.
  • Develops personal performance goals and group objectives.
  • Oversees the qualification and requalification of personnel.

 

REQUIRED QUALIFICATIONS:

Education & Experience

  • BS/BA degree in Chemistry, Life Science, or related field from an accredited college or University.
  • 7+ yrs pharma exp. with 2+ yrs supervisory experience in cGMP/pharma environment or equivalent.
  • Equivalent combinations of education and experience will be considered.
  • Experience in Sterile Injectable facility preferred.
  • Experienced in training techniques.
  • Experience in sterile product, quality assurance, quality control or packaging operations. 

 

Knowledge

  • Proficient with manufacturing operations and quality procedures to comply with regulations.
  • Maintains a working knowledge of government and industry Quality standards.
  • Solid understanding and use of ANSI sampling techniques and principles.
  • Intermediate principles of mathematical and statically computations.
  • Must have proficiency in cGMP/GLP, GLP, CFR, ISO and USP practices in a FDA regulated environment. 
  • Must have SOP, investigation, and project protocol writing skills
  • Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required.
  • Must have an understanding of cGMPs, Prior experience with regulatory (FDA) inspections.

 

Skills & Abilities

  • Able to analyze and troubleshoot problems.
  • Able to effectively handle conflict/resolution situations between different departments and inter-department.
  • Must have good verbal and written communication skills
  • Ability to interpret quality standards for implementation including ability to manage systems or processes.
  • Ability to make sound decisions about scheduling, allocation of resources, managing priorities and work hours. 
  • Ability to lead moderate to complex projects or systems.

 

PHYSICAL REQUIREMENTS:

  • Extended periods of sitting, standing, walking; reach with hands/arms; climb or balance; stoop, kneel, crawl; talk or hear; taste or smell, looking at monitor, moderate noise levels; some bus. travel. Work in cGMP environment.

ADDITIONAL INFORMATION:

  • Afternoon shift premium is 10% (non-union positions only)
  • Midnight shift premium is 15% (non-union positions only)

 

 

Endo recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.

 

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

 

*LI-ENDP