Why Endo?
We want the best and brightest people at Endo 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 Specialist, Analytical QA provides the required Quality & Compliance direction during Product Development, Regulatory Filing, Approval and Commercial Transfer for pharmaceutical products. Drives the concepts and strategies for product understanding and robustness during product development. The end result being delivery of products that have expeditious regulatory approvals and are robust to manufacture. Assures that GMPs are met for all activities related to the manufacturing/testing of clinical trial material and registration batches for development products. Provides disposition and release for clinical trial materials and registration batches. The same assurance and quality oversight is required of process scale-up and technology transfer during development, and for transitioning from development products to commercial products. This position also monitors, tracks, and trends Non-Conformances, CAPA, complaints and other Quality Systems, assesses the risk level associated with Non-Conformances and escalates the issue to management. Opportunities for continuous improvement of advanced technologies and process capabilities would be in scope of this role.
Job Description
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.
Represents Analytical Quality across the business
Key Accountabilities
- key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
Quality Assurance
- Represents Quality in full lifecycle projects and project teams to ensure that products are developed, manufactured, tested, and packaged according to applicable FDA guidelines, regulations, GXPs, and internal SOPs
- Provides counsel on cGMP requirements, with the ability to interpret regulations, guidance’s, and internal policies and apply them in the context of compliant execution of the most complex full lifecycle drug development projects
- Makes QA decisions based on knowledge and interpretation of government regulations and guidelines as well as industry standards, risk based assessments and internal policies to ensure compliance
- Reviews and approves GMP documents such as change control related documents, batch records, method validation protocols and reports, stability protocols and reports, analytical method transfer protocols and reports, and validation related documents, etc.
- Participates in the review and comment on regulatory submission deficiency responses and ensures GMP compliance
50%
Partner Oversight
- Builds relationships with development partners such as external development sites, manufacturers and labs, and with R&D teams
- Works with contractors or other staff to ensure resolution of investigations, deviations and corrective actions, etc.
- Responsible for investigations in an enterprise quality management system
10%
Batch Release
- May release products for clinical trials, tracks any associated documentation related to testing, stability, and investigations/non-conformance and corrective actions related to the batch, and reviews and approves clinical trial labels
0-15%
Quality Programs
- Participates in development and maintenance of QA programs, policies, processes, procedures and controls to ensure that products conform to established standards and agency guidelines in the interest of lasting customer satisfaction and drug safety
10%
Clinical Packaging
- For Clinical Packaging, works with Project Management and acts as the primary Quality contact for Clinical Supply labeling, packaging and distribution
- Reviews and approves GMP clinical packaging batch records, and executed clinical packaging records; follows up on deviations and quality incident investigation; resolves and tracks deviations and CAPAs for clinical packaging
5%
Metrics
- Gathers, analyzes and reports on performance Quality metrics.
5%
Best Practices
- Participates in industry forums to gain insights in emerging QA practices; applies expertise appropriately to help create ongoing improvements to development partners
5%
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
- Bachelor's degree in a scientific or related field such as Chemistry, Biochemistry, Physical Chemistry, or Industrial Pharmacy with minimum 6 years’ relevant experience at a pharma, biotech, or medical device company OR
- Master’s degree in the above referenced fields with minimum 3 years’ relevant experience
- Must have a strong understanding of generic drug developments experience
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.
- Possesses knowledge of pharmaceutical dosage forms/devices, GMPs, FDA regs and guidance documents and how to apply them to product development process and technology transfer processes
- Possesses a thorough understanding of ICH guidelines
- Able to review/approve GMP batch records, deviation investigation reports, analytical data, test reports
- Knowledge of CFR 21, Part 210 and 211
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 use Word, Excel, Outlook, Access
- Proficient in writing and verbal communications with peers, supervision, and inter-departments
- Ability to lead projects and teams
- Timely decision making
- Conflict management; and courage
- Action oriented, and driving for results
- Ability to deal with ambiguity and to negotiate
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 lab/plant/warehouse
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:
At Endo, 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.
