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Endo International Sr. Quality Specialist, Product Release (Day Shift) in Rochester, Michigan

Sr. Quality Specialist, Product Release, 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 Senior Quality Specialist, Product Release reviews all pertinent records, including Batch Production Records and laboratory Certificates of Analysis to confirm accuracy, and makes the determination of acceptability for product release. In addition, confirms that all related Quality events such as CAPAs, Change Controls, etc. are closed prior to releasing the product. Partners with other departments to ensure that errors are addressed and corrected. Identifies errors that have potential product impact, assesses compliance risk, decides when to escalate to supervision, and takes action to place lots on Quality Hold as needed. Ensures release meets internal requirements and is performed in a timely and accurate manner. Compiles timely and accurate data for business metrics, analyzes and summarizes for Quality Management Review Index. Leads or participates on cross-functional teams for continuous improvements.

ROLE AND RESPONSIBILITIES:

Quality Product Release

  • Independently reviews all pertinent records, including Batch Production Records and laboratory Certificates of Analysis to confirm accuracy, and makes the determination of acceptability for product release

  • Identifies errors that have potential product impact, assesses compliance risk, decides when to escalate to supervision, and takes action to place lots on Quality Hold as needed

  • Confirms that all Quality events (Change Controls, CAPAs, investigations and any other documentation related to the lot to be released) are complete and closed prior to product release

  • Prioritizes reviews based on production and shipment schedules

  • Under minimal supervision, reviews and approves laboratory Certificates of Analysis for accuracy, communicates with the laboratory on COA discrepancies

  • Performs MAPICS transactions to release product

  • Collaborates with Quality and Manufacturing personnel to correct errors and address Non-Conformances in a timely manner

  • Coordinates with production/ warehouse personnel to place material on Quality Hold as needed.

Metrics Data

  • Compiles timely and accurate data for business metrics, analyzes and summarizes for Quality Management Review Index

Continuous Improvement

  • Leads or participates on cross-functional teams for continuous improvements

  • Represents Quality Operations on cross-functional teams

Training

  • Provides training to less senior Quality Specialists

Compliance

  • Follows internal processes related to controlled substances

  • Follows procedures to ensure compliance to regulatory requirements

Safety

  • Follows all procedures to ensure a safe and compliant work environment

Other

  • Other duties as assigned

REQUIRED QUALIFICATIONS:

Education & Experience

  • BA/BS degree in a related discipline with 5+ years’ relevant experience, including 3 years in Quality Operations

Knowledge

  • Strong knowledge and ability to read and interpret SOPs and function within the scope of procedures

  • Thorough knowledge and ability to work with and navigate computer systems such as MAPICs and LIMS

Skills & Abilities

  • Ability to handle and integrate multiple pieces of data to assure correctness

  • Ability to effectively train other specialists

  • Ability to work with cross-functional teams

  • Able to recognize and identify complex errors such as calculation conversions

  • Able to reconcile batch record entries with other documentation

  • Proof-reading skills and ability to identify errors

  • Customer/stakeholder focused, understands impact of daily work to compliance and business

  • Communication skills

  • Strong basic math skills

  • Ability to follow complex processes

  • Attention to detail

  • Strong documentation skills

PHYSICAL REQUIREMENTS:

  • Lift 15 lbs.

  • Walk across plant/warehouse

  • Wear appropriate gowning/PPE as required

  • Ability to read for extended periods of time

ADDITIONAL INFORMATION:

  • Afternoon shift premium is 10% (non-union position 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

Individuals seeking employment are considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity record keeping, reporting, and other legal requirements.

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