Job Description Summary
The Sr. Quality Analyst has responsibility for Product Release and Maintenance of Monthly Quality Metrics and Daily Notification to Management. Additionally, the Sr. Quality Analyst will provide support for customer inquiries, gap assessments, customer audit coordination, and inspection readiness. batch record review, and label preparation as assigned. They will serve as secondary back-up for batch record review and label preparation as needed.
Job Description
ESSENTIAL FUNCTIONS:
- Utilize inventory management systems and other associated quality systems to ensure proper release of product for the Raleigh manufacturing site.
- Function as a Primary back-up for the Raleigh site gap assessments and customer inquiries and coordinates organization of required documentation for GMP customer requests with guidance from manager.
- The role will provide support for various elements of Quality including but not limited to the following: GMP NEO Training, Annual Product Review, Management Review, Audits, Product Complaints, CAPA, and Change Control.
- Maintenance of the Site Internal Audit Program.
ADDITIONAL FUNCTIONS:
- Function as a secondary back-up for batch record reviews. This includes providing timely and thorough audits of all product batch records to ensure site compliance with cGMP regulations, picking up all batch records to be audited from the plant and returning all audited records to the plant (minimum is once daily but could require multiple trips), and providing batch record training as needed for all production employees and potential new QA Analysts.
- Function as secondary back up for label preparation. This includes programing label changes and adding new codes to the labeling computer. Makes, proofs, and records all finished lot labels to meet the production schedule and as requested by production personnel. Issuing final product labels and batch records to production.
- Assist as needed with archival of batch records to including but not limited to, batch record scanning, documentation error tracking and corrections, and label reconciliation.
- Performs administrative activities for the Quality department. This includes ordering supplies and other materials for both QA and QC as well as filing.
- Provide support to investigations, both exceptions and OOSs, to support product disposition.
- Corresponds with customers via routine customer inquiries.
- Provide support to intermediate labeling and tank inspections as needed.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Other duties as assigned with or without accommodation.
- Participates in a certified 5S Workplace System to ensure good housekeeping and organization.
- Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy.
- Effectively trains and works with others in a positive manner.
- Provide administrative duties for the department, such as mail distribution, coordination of supplies, and maintenance for the fax and copy machines.
MINIMUM REQUIREMENTS:
Education:
B.S. degree in equivalent life science preferred, other degrees may be considered with relevant experience.
Experience:
Competency in MS Word, Excel, and Adobe is required.
Minimum 5 years’ experience in QA or a pharmaceutical manufacturing environment, other relevant experience may be considered.
Preferred Skills/Qualifications:
Other Skills/Competencies:
Knowledge of regulations associated with ICH Guidelines (Q7, Q8, Q9, and Q10), FDA, EMA, USP, EP, and JP.
Thorough knowledge of quality procedures and GMPs to appropriately audit and perform records functions associated with site compliance to FDA regulations.
Good project management, problem solving, team building, and negotiation skills.
Strong technical, oral, and written communication skills.
Able to plan and execute tasks on multiple projects simultaneously.
Diligence, organization, time management, and effective communication are needed for this position. A high degree of concentration is required to prevent mix-up and consequent quality release errors.
RELATIONSHIP WITH OTHERS/ SCOPE:
- This position reports to the Quality Manager and indirectly to the Site Quality Director
- Ability to understand the timely nature of work, quick reporting of results, and fast changing of priorities are necessary to complete assigned tasks.
- Sound judgment must be used in evaluating plant compliance with GMP standards and initiative is required to facilitate changes needed. An error in judgment during audits could result in FDA citations to the company.
- A good working relationship with various levels of personnel and management.
- Good coaching skills are required when providing assistance and guidance to site internal auditors.
- No employees directly reporting to this position.
- This position requires self-motivation and daily execution of tasks with limited supervision interaction.
WORKING CONDITIONS:
- General normal office and meeting room conditions but must complete some routine assignments in plant and non-air-conditioned production environment.
- Ability to adjust schedule as needed to accommodate production, release, shipping needs.
- Must be willing and able to wear PPE including hard-hat, steel-toed shoes, safety glasses and any other devices or equipment as specified for the position.
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.
