Tergus Pharma is currently recruiting for a Quality Assurance Specialist & Manager Quality Control & Stability Operations. These positions will contribute to Tergus Pharma's overall success by ensuring compliance with GMP/GLP regulations, Analytical, Stability Data and Data Review, documentation compliance, and internal lab procedures within a GMP/GLP analytical and manufacturing facility.
Review and approval of analytical documentation including methods, validation protocols, analytical data and reports (release, stability and validation).
HPLC data review in Waters Empower 3
Maintain and support completion of, including but not limited to, SOPs, Specifications, MBRs, LIRs, OOS, Deviation, CAPA, Complaints, Change Control, Equipment Qualification/Validation, Methods and Protocols
Track and trend quality system metrics such as LIR/OOS, DEV, CAPA, Change Control and Customer Complaints.
Perform CAPA review, approval and effectiveness checks.
Support the vendor qualification program (documentation, audits, etc.).
Perform facility and quality system audits.
Quality Assurance review and approval of instrument/equipment calibration documentation, investigations, deviations, CAPAs and change controls.
Quality Assurance review and approval of manufacturing documentation, including specifications and release, batch records, and batch release.
Approval of QC analytical test methods, protocols and specifications;
Management of the teams to ensure the workload is scheduled appropriately to meet customer Release testing schedules and stability pull dates and timelines.
Ensure all data is reported through the appropriate channels of communication – Customer Certification of Analysis to external and
stability databases internally.
Oversight for review of QC and Stability data for compliance with Customer Requirements and specifications and regulatory requirements
Managing, Develop, and Maintain a diverse professional staff of Analytical Scientists and Data Reviewers with responsibilities for in- process, finished
products, raw materials release, stability sample testing, analytical method development validation.
Manage staff while promoting team collaboration and ensuring balance of workload and responsibility.
Quality Assurance Specialist - Required Qualifications and Skills:
B.A. or B.S. in a scientific discipline.
4 - 6 years' experience in a Quality Assurance / compliance role in a GMP/GLP-compliant pharmaceutical, analytical environment
2+ years of analytical laboratory experience and/or process manufacturing knowledge
Experienced using Waters Empower 3 software.
Proven ability to review and evaluate the content of documentation; conscientious about attention to detail; uses logical thinking that is well organized and methodical
Proven ability to collaborate with technical staff with minimal management
Able to multi-task productively, applying time management processes and procedures effectively
Technically capable of determining what is wrong in complex situations and offering potential solutions, identifying root cause of a problem and working with others to correct problems
Works toward common goals by supporting, encouraging and sharing information with colleagues
Speaks, writes, listens and presents information in a logical and articulate manner
Manager Quality Control & Stability Operations - Required Qualifications and Skills:
B.S. in a scientific discipline.
8+ years' experience in a Quality Assurance role in the pharmaceutical industry
Must have at least 3 years of recent CMC regulatory experience.
Experience in managing Analytical and Stability Teams
Experience using SLIM software for collection and calculation of Stability data and trending.
Experience in Data Review of Analytical data per GDP guidelines.
Proven ability to review and evaluate the compliance and completeness of analytical data.
Thorough knowledge of GxP regulations
Proven ability to collaborate with technical staff and customers
Is thorough when performing work; conscientious about attention to detail; uses logical thinking that is well organized and methodical
Able to multi-task productively, applying time management processes and procedures effectively
Technically capable of determining what is wrong in complex situations and offering potential solutions, identifying root cause of a problem and working
with others to correct problems
Works toward common goals by supporting, encouraging and sharing information with colleagues
Speaks, writes, listens and presents information in a logical and articulate manner
NOTES:
2 openings.
About Tergus Pharma
Tergus, an end-to-end service provider for topical pharmaceutical research, drug development, testing and manufacturing company, has been an industry leader for several years with a state-of-the-art facility in Durham, North Carolina. The company has a long and stellar reputation for delivering quality results to clients from formulation through clinical supplies manufacturing, which is why people say, “Think Topicals, Think Tergus.” A systematic and scientific approach is used to thoroughly understand product components, processing, and finished product attributes to ensure high quality product throughout the course of development. Tergus helps its client achieve a balance between a fast-tracked program and quality science. For more information, please visit https://www.TergusPharma.com/
