Quality Specialist II, QA Production Support and Incoming QA, 2nd Shift (M-Th 4:00pm - 2:30am)
Purdue Pharma L.P. and its subsidiaries develop, manufacture and market medications and consumer health products to meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians, and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to supporting national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue is pursuing a pipeline of new medications through internal research & development and strategic industry partnerships.
For close to two decades Purdue has engaged in many initiatives to stem prescription opioid abuse. We are committed to bringing lifesaving relief to communities and individuals suffering from substance use disorder and overdose. We are currently developing or supporting the development of two essential life-saving opioid overdose reversal medications and have the capability to manufacture others for medication assisted treatment. Providing these medicines has the potential to improve and save countless lives.
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We are building an exciting path forward, and we are committed to recruiting a dedicated team of professionals who advance our expertise through a commitment to Purdue’s Values: Integrity and Courage, underpinned by Innovation, and always in Collaboration with each other.
At Purdue Pharma and our subsidiaries, you have a unique career opportunity to work differently, uncover and seize new opportunities, and take a hands-on, ownership approach to your work. We go beyond traditional roles and find creative ways to extend our skills and interests, challenging ourselves to contribute in different, meaningful ways. We strive to create an environment where you can bring your best to work each day. We welcome the opportunity to have you on our team!
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The Quality Assurance (QA) Specialist II, QA Production Support is a position on the Second Shift. The candidate must demonstrate thorough understanding, knowledge, and ability in primary discipline. The QA Specialist II, QA Production Support is responsible for performing incoming sampling of materials, support room /line clearances and provide QA input into production event resolution to assure that quality operations are in conformance to GMP requirements. Also responsible for identifying compliance deficiencies, providing QA SME input into investigations as required and assisting with the resolution plan.
- Perform sampling, and inspection on incoming commercial and experimental/clinical raw materials, components, and intermediates.
- Perform raw material component review to ensure correct quantities, labeling and visual appearance.
- Oversee the administration of the prompt event evaluation, investigation, closure and follow-up of process/equipment discrepancies and related areas as well as identify opportunities for continuous process improvements.
- Comprehend and adhere to all related SOPs, company policies, cGxPs, and regulatory requirements.
- Comprehend and adhere to all pertinent Health and Safety regulations, policies and procedures and the required use of all approved and issued Personal Protective Equipment.
- Maintain current training status and close all training gaps in a timely fashion.
- Provide timely day-to-day decisions on compliance related issues in Production, Warehouse/Distribution, Facilities, Incoming QA, Quality Control and Stability areas based on expertise and collection of independently gathered information.
- Assess accuracy and compliance of plant SOP’s as a SOP reviewer and approver and works with SOP author for timely approvals.
- Communicate daily with supervision and others within work group as related to specific job function and demonstrate the ability to communicate with others outside of work group.
- Demonstrate a level of consciousness to safety and health related activities as evident by the daily application of requirements specific to job function; Recognize safety and health related issues and report to supervision.
- Performs other related assignments and duties as required and assigned.
- Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments.
Education and Experience
BS required for external candidates with 2 years minimum relevant experience, or equivalent level of experience in pharmaceutical or related industries; or graduate degree (MS Preferred) with one-year minimum experience.
Necessary Knowledge, Skills, and Abilities
- Basic understanding of applicable regulatory requirements as it relates to job function demonstrated by adherence to policies and procedures
- Basic ability to perform computer transactions related to job functions demonstrated by right first-time measures
- Performs job function using appropriate instrumentation and applicable techniques demonstrated by efficient and accurate completion of work
- Applies technical knowledge and experience in performing job functions as is displayed through independence in daily performance of work
- Applies and evaluates systems and procedures for improvement opportunities demonstrated through discussion of recommendations with supervision
- Overcomes obstacles to achieve results as indicated by ability to resolve issues and meet timelines
- Demonstrates application of industry best practices and specific regulatory requirements for evaluation of systems and procedures for improvement opportunities and communicates results and ideas to supervision on a regular basis.
- Troubleshoots and recommends improved methods or techniques of performing job function or utilizing instrumentation demonstrated by ability to achieve results, gain right first-time output, and improve efficiency
- Ability to utilize multiple IT systems required for job performance and utilize reports for analysis demonstrated by consistent right first time results and independent resolution of issues
- Completes required documentation accurately according to procedure
- Identifies potential concerns in data that is reported and communicates concerns to supervision
- Performs peer review of data with consistency and accuracy, and assists in resolution of documentation errors
- Identifies unusual occurrences or data that is aberrant as compared to acceptance criteria or routine analysis
- Documents and evaluates technical data for indications of negative trends and reports trends to management
- Summarizes and evaluates data for reporting and analysis and reports results to management
- Independently resolves documentation errors with other appropriate departments achieving acceptable corrective action
- Acts as reviewer of data generated in work group with consistency and accuracy, and assists in resolution of documentation errors
PROBLEM SOLVING COMPETENCIES
- Recommends solutions to issues related to the job function in a timely manner
- Troubleshoots and provides immediate solutions for issues related to job function
- Executes corrective actions to prevent reoccurring problems
- Demonstrates ability to communicate with others outside of work group as related to the specific job function
- Contributes to functional areas outside of work group contributing expertise as related to the specific job function
- Evaluates work related activities to eliminate potential safety or health related issues and implements corrective action
Supervisory Responsibilities (if Applicable)
There are no direct reports for this role.
- Job Family Quality
- Pay Type Salary
- Wilson, NC, USA