Manager Quality Control (Stability and Reference Standard Focus)

Cambrex•High Point, NC

About The Position

Come join our QC team of experts. This role will manage and direct Quality Control scientific staff. Focus efforts of self and team on analytical support with analytical activities involving the stability and reference standard programs. Enhance efficiency of current systems. Mentor and develop team members. Seek innovative cost and scientific solutions. Ensure compliance with applicable Company SOPs and regulatory guidelines.

Requirements

Excellent verbal and written communication and interpersonal skills, problem-solving, and organizational skills.
Track record of successfully applying high level judgment in a variety of complex and unprecedented situations. Proven ability to act independently to achieve pre-determined goals and objectives and obtain desired results. Ability to coach and develop staff and to transfer job knowledge and skills.
Ability to integrate input/data from diverse sources and create new and innovative solutions. Demonstrated ability to apply technical, functional, and industry knowledge to design and execute projects that shape the strategic direction of one or more projects. Other demonstrated abilities: work in a diverse team environment; foresight and judgment in planning, organizing, and guiding complex projects; making complex decisions and troubleshooting in ambiguous situations. Exposure to broader analytical techniques (i.e., beyond just USP compendial testing).
BS, MS, or PhD in Chemistry (or closely related discipline).
A minimum of at least 7 plus years’ experience in QC (or similar role) with 2 plus years’ experience managing others in a laboratory environment (prefer in a GMP/QC-compliant pharmaceutical laboratory environment) with focus on ICH stability testing.
Strong Quality Control, compliance, scheduling, and organizational skills and insight. Expertise in most common analytical techniques/technologies (e.g., HPLC, GC, LC/GC/MS, IR, Empower, etc).
Expertise in USP compendial and other technical application testing and in OOS investigations. Expertise in creating and interpreting SOPs. Ability to function as technical expert/consultant.

Responsibilities

Manage/coordinate/drive efforts of staff in stability plan design and coordinating the activities that support the entire stability lifecycle of the study.
Manage/coordinate/drive efforts of staff in the design of stability protocols and reports in accordance with ICH guidelines and publishing in MasterControl with adherence to associated SOPs.
Manage/coordinate stability study set down to fraction and stage materials.
Track/monitor all active stability programs including pull dates and report issue dates.
Ensure stability inventory is correct and up to date.
Manage/coordinate/drive efforts for reference standard management and retesting program.
Track/monitor all current reference standards to plan for the testing and timely delivery of certificates.
Provide training/development for specified laboratory staff on the stability and reference standard program.
Routinely represents the department on stability and reference standard topics in internal or external meetings, with clients, and during audits.
Assure compliant, staffed analytical laboratory support.
Write deviations, assist/lead laboratory investigations, and assist in CAPAs relative to stability and reference standard program.
Recommend/justify new/additional equipment, staffing or organizational positions, promotions.