Job Description

Why Us?

We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

The Quality Associate Specialist, Product Release, under close supervision, reviews all pertinent records, including Batch Production Records and laboratory Certificates of Analysis to confirm accuracy and, with guidance, 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, escalates 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.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Job Description

Supports one component of the Generics business, mainly within a single site.

Quality Product Release

• Reviews, under close supervision, all pertinent records, including Batch Production Records and laboratory Certificates of Analysis to confirm accuracy and, with guidance, makes the determination of acceptability for product release
• Identifies errors that have potential product impact, escalates 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
• With guidance, reviews 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

Compliance

• Follows internal processes related to controlled substances
• Follows procedures to ensure compliance to regulatory requirements

Continuous Safety

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

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

• BA/BS degree in a related discipline with 0-1 year of relevant experience
• Experience in Quality Operations preferred

Knowledge

Proficiency in a body of information required for the job

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

• Basic knowledge and ability to read and interpret SOPs and function within the scope of procedural requirements
• Knowledge and ability to work with and navigate computer systems such as MAPICs and LIMS

Skills & Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

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

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

EEO Statement:

We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

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