Quality Specialist, Analytical QA
Job Summary - a concise overview of the job
The Quality Specialist, Analytical QA provides the required Quality & Compliance direction during Product Development, Regulatory Filing, Approval, and Commercial Transfer for pharmaceutical products. Drives 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. Ensures GMPs are met for all activities related to manufacturing/testing of clinical trial material and registration batches for development products. Provides disposition and release for clinical trial materials and registration batches. Ensures the same during process scale-up and technology transfer during development, and transitioning from development products to commercial products. Ensures all applicable GMP contractors are qualified and Quality Agreements are in place.
All incumbents are responsible for following applicable Division & Company policies and procedures.
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 Generics business
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
§ Supports QA on Generic pharmaceutical development project teams to help assure quality standards, product understanding, and robustness are met during product development
§ 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. Activities include review and approval of GMP documents pertaining to the projects: change control-related documents, batch records, method validation protocols/reports, stability protocols/reports, analytical method transfer protocols/reports, validation related documents, etc.
§ Reviews and comments on ANDA applications, ANDA amendments and ANDA deficiency responses
Document Review & Approval
§ Performs batch record review, comments resolution, and releases product for clinical trials. Tracks associated documentation related to testing, stability, and investigations/deviations/non-conformance and corrective actions related to the batch.
§ Reviews and approves clinical trial labels
§ With guidance, reviews and approves business and contractor documents pertaining to products (change control-related documents, master batch records, stability reports, validation related documents and Quality Agreements, etc.)
Stability Program and Data Analysis
§ Monitors stability program. Ensures gathering of data, out-of-specification investigations, summary reports are timely and compliant for product development for ANDAs submission
§ Builds relationships with development partners such as external development sites, manufacturers and labs, and with R&D teams
§ Conducts appropriate audits, quality agreement development, qualification and ongoing oversight of external development partners
Investigations & Deviations
§ Reviews, approves and tracks investigation/deviations and corrective actions
Policies & Procedures
§ Participates in the development and maintenance of QA programs, policies, processes, procedures and controls to ensure that products conform to established standards and agency guidelines
§ Participates in the development and implementation of process related improvement in areas related to quality and compliance
§ Participates in industry forums to gain insights in emerging QA practices; applies expertise appropriately to help create ongoing improvements to development partners
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 3 years’ relevant experience at a pharma, biotech, or medical device company
§ Must have an understanding of generic drug development
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Knowledge of pharmaceutical dosage forms/devices, GMPs, FDA regulations and guidance documents and how to apply them to the product development process and to the technology transfer processes
§ Thorough understanding of ICH Q7, Q8, Q9, Q10 guidelines
§ Demonstrated ability to adhere to timelines to ensure successful and on time development of generic drugs development
§ Understanding of bioequivalence or bioavailability studies
§ Understand the ANDA submission and review processes
§ Knowledge of CFR 21, Part 210 and 211
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.
§ Review and approve GMP batch records, deviation investigation reports, and analytical data & test reports
§ Ability to use Word, Excel, Outlook, Access
§ Proficient in writing & verbal interdepartmental communications with peers & supervision
§ 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 negotiate
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
§ Travel up to 10% including international travel for project meetings or audits.
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.