Senior Director QA/QC & Technical Services

Overview

USAntibiotics, the only U.S. manufacturer of Amoxicillin products, is part of the Jackson Healthcare family of companies. We're always looking to add new talent to our teams, and we value diverse professionals who have strong leadership skills, align with our culture, and are committed to excellence.

ROLES & RESPONSIBILITIES:
* Perform technical duties in specialized area or function as leader in absence of management, as assigned. Assist laboratory supervisors with tasks, as needed.
* Perform efficient and reliable analytical tests following validated procedures for a wide variety of methods and sample types as assigned.
* Document all results in accordance with cGMPs and written procedures.
* Trouble-shoot and solve problems with assays and equipment with little or no supervision. Report all observations.
* Recommend changes to methods and operations as appropriate.
* Interpret analytical results correctly, notifying Management promptly of both situations that indicate analytical issues and manufacturing or product issues.
* Develop/implement appropriate corrective and preventative actions (CAPA)
* Lead and write lab investigations and support manufacturing plant investigations by established procedures and in accordance to FDA regulations.
* Maintain the QC laboratories to comply with cGMP and USAntibiotics standards of safety, quality, and cleanliness.
* Participate in analytical method validations or transfers as required.
* Perform satisfactorily on all analyst qualification studies, indicating technical proficiency.

* Plan, perform, and document non-routine tests (or special studies) and investigations under the direction of Manager/Director.
* Collaborate within and abreast to QA, QC, and Technical Services teams to ensure timely and compliant support to manufacturing.
* Participate in cross-functional projects, investigations, and improvement initiatives.
* Act as technical liaison during interactions with vendors, regulatory inspectors and internal teams.
* Evaluate and utilize state-of-the-art equipment including automated systems and computerized systems to perform testing and meet the goal of improved assay performance, including reliability , cost and assay characteristics.
* Maintain and improve proficiency of operations through training.
* Write validation reports, analytical procedure SOPs and equipment SOPs as required.
* Notify Management of any SOPs that may require revision and initiate change requests per written policy, providing sufficient evidence/documentation to support change request.
* Conduct special studies in accordance with protocols and direction of management. Prepare well documented reports of results.
* Carry out other departmental duties as deemed appropriate by the respective Manager/Director.
* Broaden understanding of subtleties of the techniques utilized by keeping current with technical and professional literature, attending technical discussions both inside and outside the USAntibiotics community.
* Provide technical and professional expertise to less experienced staff in the laboratory.
* Serve as technical resource during Regulatory inspections and internal audits as required. Also, conduct internal audits and self-inspections as required. Provide information to outside vendors and technical representatives in a professional manner.
* Review (i.e., validate) and approve analytical results for other laboratory personnel as assigned.
* Responsible for calibrating and maintaining assigned laboratory equipment according to schedules and procedures, documenting all results.
* Lead equipment qualifications, drafting protocols and summary reports, as directed by management.

* Specialized area of responsibility as assigned:

• o Analytical Methodology/Instrumentation Mastery
• o Empower
• o LMS
• o QMS
• o LIMS
• o SAP
• o Compendial/Regulatory Expertise

* Perform analyst qualification studies, indicating technical proficiency to support troubleshooting analytical testing.
* Support any special studies as needed in accordance per protocols and direction of management. Prepares well-documented reports.
* Advises management of any potential improvements, ideas, or changes to methods.
* Completes technical writing as required, e.g., revision of analytical procedures, equipment-related SOPs, results, summaries, initiates change requests as required. Reviews entry and junior specialists' change requests to support the growth and development of the team.
* Evaluates and utilizes state of the art equipment, including automated systems and computerized systems to perform and document testing and meet goals of improved performance, including reliability and efficiency.
* Assists the Quality unit in meeting goals, business objectives, and production plans.
* Propose ideas for operational changes in QA, QC, and TS laboratory to improve cGMP compliance, efficiency, cost, and performance.
* Create technical documents such as change controls, validation protocols (equipment, facilities, and cleaning), and summary reports.

QUALIFICATIONS - EDUCATION, WORK EXPERIENCE, CERTIFICATIONS:
* Phd/BS degree in Chemistry (or related science) or equivalent related analytical experience.
PREFERRED QUALIFICATIONS:
* Master's Degree in Chemistry (or related science) and/or approximately seven (7) years scientific work experience, which includes a specialized skill.
* Previous pharmaceutical industry experience required.
EXPERIENCE REQUIRED:
* Minimum of 7-10 years of analytical experience in pharmaceutical industry and/or other scientific experience.
* Strong knowledge/experience of cGMPs in areas beyond QC laboratory such as compliance with QA and applicable regulatory standards that impact lab operations.
KNOWLEDGE, SKILLS, AND ABILITIES:
* Demonstrated ability to perform a wide variety of chemical, instrumental, and chromatographic analyses.
* Demonstrated mastery of skills at Chemist level and/or expertise in specific topic.
* Advanced computer skills.
* Advanced method development and trouble-shooting skills.
* Thorough understanding of chemical theory on which test methodology is based with strong laboratory testing skills.
* Appropriate interpersonal and leadership skills.
* Advanced verbal and written communication skills.
* Ability to prioritize and decide appropriate course of actions. Consistently notifies Management of possible compliance and technical issues and suggests/implements corrective actions.
* Ability to handle multiple priorities efficiently and make/implement decisions.
* Fully versed in cGMPs, FDA, and other regulatory agency requirements.

* Ability to function independently on special projects and follow through to successful completion.
* Ability to maintain confidentiality.
* Ability to work in a team multi-disciplinary environment interacting on a professional level with peers, subordinate and senior personnel.
ACCOUNTABILITY:
* Assures that testing of products manufactured at the facility is performed by approved procedures and appropriate regulations and that lab operations conform to company standards for safety and performance.
* Performs technical functions based on mastery of specialized topic and advises/assists less experienced personnel in the laboratories.
* Assures the quality of laboratory documentation, i.e., documentation is comprehensive and accurate.
* Provides leadership in the laboratory in the absence of Management and make appropriate decisions.
regarding product release and quality.
* Assists laboratory supervisors with duties, as needed.
COMPLEXITY:
* Serves as backup to management for routine lab operations and in planning laboratory investigations, determining validity of results and appropriate actions
* Advises in a technical role less experienced staff, notifying Management of problems/issues or additional training needs.
* Performs statistical analysis as required for annual product reviews, special studies, investigations, etc. Also must use judgement to raise possible issues to upper management.
* Initiates operational changes in laboratory, within constraints of policies and procedures to improve cGMP compliance, efficiency, cost, and performance
* Assures the integrity of analytical results/documentation generated.
* Assists the Quality Assurance Department in meeting goals established.
TRAVEL REQUIREMENTS & WORKING CONDITIONS:

* The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
* While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; write; type; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and smell.
* The employee must on occasion lift and/or move up to 50 pounds.
* Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

EEO Statement

USAntibiotics is an EEO/AA Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender, gender identity and expression, national origin, age, disability or protected veteran status. We celebrate diversity and are committed to creating an inclusive environment for all of our associates.