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This role is in support of American Health Packaging, a Cencora business offering pharma packaging services in the US.
Under the general direction of the Sr. Manager, Regulatory Affairs & Stability, the Quality Control Lab Manager is responsible for the management of the AHP Quality Control Chemistry and Microbiology Laboratories. Producing and managing the execution of technical method transfers between suppliers and the AHP laboratories, leading investigations of unexpected laboratory results and coordinating communications with suppliers.
This job position is compliance critical and responsibilities include ensuring continual and proper compliance with all division, corporate, and government regulatory requirements. It is the associate’s responsibility to observe all safety rules. Any condition thought to be hazardous or unsafe should be reported to your supervisor immediately.
Directs, leads, trains and mentors the Laboratory Associates.
Provides direction of daily tasks.
Prioritizes workload for department.
Set departmental objectives for strategic alignment to site goals within the Quality Assurance function including monthly metrics and trend data.
Produce and manage the execution of technical method transfer activities between supplier and AHP laboratories.
Oversee the creation of test methods and method transfers to bring additional products into the AHP laboratories.
Lead laboratory investigations for out of trend results and coordinate the communications between supplier and AHP laboratories and document in MasterControl.
Perform trending analysis for laboratory metrics data to identify potential areas of concern in analytical reproducibility.
Manage the Environmental Monitoring program and TOC equipment and water sampling for micro.
Responsible for the laboratory testing of micro samples for LUD product release.
Perform review and entry of stability data.
Support Quality Investigations team with requested analysis.
Utilize process improvements to gain efficiency while maintaining quality.
Assure all associates follow cGMP and safety procedures.
Create, revise and maintain Stability documents using a (DCS) Document Control System such as MasterControl and Stability software such as NovaTek
Ensure stability and release testing activities are compliant with FDA, DEA, other regulatory body requirements as applicable. Ensure compliance with local and corporate policies and procedures.
Oversee stability and release testing for drug products in accordance with compendial and global requirements, as applicable.
Develop, revise, and review standard operating procedures (SOPs), work instructions (WIs), and test method documents to ensure compliance with applicable compendia and regulations.
Assist in the support of manufacturing operations including process validation, environmental monitoring, and utilities as applicable.
Perform review of stability and release tests for compliance to SOPs and regulatory requirements and ensure data is reported accurately.
Prepare lab reports as required.
Assist with root cause investigations for quality incidents.
Maintain Quality System records and ensure completeness and accuracy.
Coordinate with department management to identify and implement compliant process improvements.
Clarify regulations, policies, and procedures to internal teams as applicable.
Coordinate with departmental leaders to develop appropriate corrective actions resulting from investigations, internal audits, and facility inspections.
Conduct follow-up checks on the effectiveness of corrective actions
Performs other duties to support Quality Systems and Regulatory Affairs department as assigned.
Develop clear objectives for team members in support of their development, progression, and career path.
Conduct performance management reviews.
Education & Experience:
Bachelor’s degree in chemistry or related field required.
Seven or more years’ experience within a pharmaceutical manufacturing (cGMP) laboratory environment.
Should have a working knowledge of pharmaceutical manufacturing requirements, Quality System principles (Documentation, Training, Investigations/CAPA, Change Control, etc), and global Quality Control regulations.
Must have experience in pharmaceutical stability testing (HPLC, Dissolution, Related Compounds, etc.), trending analysis and investigation of unexpected results. Experience with method transfer protocols, stability testing and data analysis for testing of pharmaceuticals.
Experience with MasterControl or other electronic quality management system preferred.
Skills & Knowledge
Good oral, written, communication, and interpersonal skills.
Ability to develop and maintain cooperative working relationships with others.
Effectively interfaces with multiple levels of associates within the organization, including management and plant associates.
Ability to work independently.
Ability to handle a variety of tasks simultaneously.
Attention to detail.
Familiarity with concepts of electronic documentation management systems (EDMS).
Physical & Mental Requirements:
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions:
Physical activity requiring reaching, bending, kneeling, stooping, lifting, finger dexterity, grasping, feeling, repetitive motions, talking and hearing.
Ability to lift up to 50 lbs.
Visual requirement is for close vision, distance vision, peripheral vision and ability to adjust focus.
Associate is required to stand, walk (or otherwise be mobile).
Ability to deal with stressful situations as they arise
We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora
Full time
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Affiliated Companies: AmerisourceBergen Drug Corporation
