Senior Quality Specialist, Product Release Job at Endo International
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. Participates in reviews and structured processes for continuous improvement. Represents Quality Operations on cross-functional teams.
Scope of Authority
- span of control
(work unit, site, department, division, etc.)
, monetary value of budget/spend authority
( capital, operating, etc.),
P&L responsibility, etc.
- Supports one component of the Par business
- Completes assigned tasks independently based on established procedures. No instruction needed on routine work
Key Accountabilities
- key
outcomes/deliverables,
the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
Floor
Operations
- Performs physical inspection of in-process and finished product samples as assigned and according to the production schedule
- Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements
- Is competent in at least three or more processes (weighing, compounding, mixing, packaging, granulation, compression, coating, Liquids Mfg. and Batch Transfer, Creams & Ointments Mfg. and Batch Transfer, Packaging, etc.)
- Follows internal processes related to controlled substances
- Performs GMP related verifications including area, equipment and line clearances, cleaning, room inspection, material verification, etc. according to procedures
- Collects and appropriately labels Packaging retain samples, and submits to the archive storage
- Quarantines water ports as necessary
- Actively participates in process validation and equipment qualification activities
- Ability to work on stretch assignments (ex. Defect evaluation)
- Participates in resolving complex issues
- May execute computer data entries in CME, JDE, LIMS, and department databases
- Sampling and inspection of raw materials, packaging components, in-process, bulk, and finished drug product during manufacturing and packaging operations of commercial and non-commercial processes
- Maintains collection of hold time study samples for QC analysis
- Collects and retains samples and performs sample evaluation for APR
- Performs manufacturing/packaging stage reviews of batch records
- Files and archives records as needed
- Monitors movement of controlled substance within their designated facility to and from secured location
- Backs up QA reviewer of environmental monitoring alarms
70%
Non-Conforming Events
- Responds to and escalates events identified during production to Quality Management
- Participates in Non-Conformance investigations as part of the Rapid Response Team and helps drive root cause determination
- Writes Non-Conformance investigations
- Provides quality direction to operations to resolve floor issues, implement corrections, and assure deviations are opened
20%
Process Improvement
- Participates as a Quality representative on process excellence initiatives, Kaizen events and special projects
- Participates in gap analysis and recommends revisions to SOPs
- Collaborates with Manufacturing and Quality partners to identify and implement improvements
10%
Compliance
- Conducts GMP walkthroughs of facilities
- Performs in-process audits to identify adherence to SOPs and BPR requirements
- Trains more junior Quality Associates as a Qualified Trainer
- Actively participates in training events, and maintains currency with assigned training requirements
- Facilitates shift meetings
continuous
Safety
- Follows all procedures to ensure a safe and compliant work environment
continuous
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
- High school diploma or equivalent with 6-10 years’ relevant experience OR
- AA/AS degree with 5-9 years’ relevant experience OR
- BA/BS degree with 4-8 years’ relevant experience
- Related discipline and certification in assigned area a plus
- Experience in a lead role a plus
- Experience with statistical sampling methods a plus
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.
- Has solid understanding of cGMP
- Ability to communicate and work with teams
- Attention to detail
- Strong documentation skills
- Ability to read and interpret SOPs and function within the scope of procedures
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.
- Strong proficiency with basic math skills and basic experience with computers and software applications required
- Able to communicate effectively with other departments, management and operational personnel
- Customer/Stakeholder focused (understands impact of daily work to compliance and overall business)
- Proof-reading skills; ability to identify errors
- Ability to read and comprehend documentation and requirements set forth in Batch Production Records (BPRs)
Physical Requirements
Physical & mental
requirements
e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
- Lift 15 lbs.
- Walk across plant/warehouse
- Wear appropriate gowning 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.
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