Mgr, Quality Control

Merck•Wilson, NC

2d•Hybrid

About The Position

POSITION OVERVIEW - Basic Functions & Responsibility Essential functions include, but are not limited to: Under the general direction of the Director, Wilson Q.O., the Manager is responsible for administration of NASU and Wilson laboratories. The Manager or "Coach" ensures that all compliance regulations, cGMPs, and internal guidelines are adhered to and/or enhanced. The Manager manages activities to implement productivity enhancements to streamline activities. TI1e Manager executes activities to meet or exceed customer expectations through a staff of professionals at the B.S., BA, M.S., and Ph.D. levels.

Requirements

B.A./8.S. degree (preferably in Science or Engineering)
Knowledge of continuous improvement principles
Minimum of 5 years of pharmaceutical experience

Nice To Haves

Deviation Management / Root Cause Analysis
Background in technical writing
Experience with complex investigations and CAPA resolution
Experience applying 5S concepts
Experience with SAP, Data Integrity, cGMP, 21CFR requirements, ISO 13485, laboratory analysis principles and execution, MEDS, GLIMS, laboratory equipment qualification, method transfer, change control, and stability principles
Previous management experience

Responsibilities

Drives continuous improvement and supports sustainability of implemented changes identified through such lean tools or champions new actions as a result of data obtained through lean methodology.
Responsible for the necessary personnel and equipment resources to perform technical support, microbial testing, stability testing, release testing, supplies inspection, copy reading, API testing to ensure that customer expectations are met or exceeded.
Aligns resources with business unit needs.
Actively participates in Plant/Quality committees and works with other QO groups, Planning, Manufacturing, Packaging, Maintenance, and others as required to resolve problems, and satisfy quality and production needs.
Responsible for knowledge of cGMP's, and laboratory safety, as well as the transfer of that knowledge to employees. Routinely makes decisions using cGMP and safety knowledge as a guide.
Edits, writes, and/or approves departmental SOPs and investigations.
Acts as a key regulatory compliance liaison to interface with regulatory agencies during audits of assigned areas. Performs duties and responsibilities of the Director in his/her absence.
Reports to the Quality Director for general advice and instruction, but normally handles routine matters independently, consulting on major problems only.
Manages a staff of Associate Specialists, Specialists, and others as needed
Responsible for administrative and personnel actions such as hiring, transfers, training, salary and appraisal administration.
Manages activities to identify and correct problems, emphasizing prompt and definitive resolution to minimize adverse impact and reoccurrence.
Manages QC area in accordance with company policy and applicable government regulations. Makes provisions to assure job responsibilities of the QC area are conducted in a timely and reliable manner to meet production demands.
Ensures that all contemporary policies (SOPs, QSs, SATs, Departmental Policies,) are maintained and adhered to within the laboratory. Participates in the generation and interpretation of divisional policies/guidelines.
Supports initiatives that involve the necessary human and capital resources needed to meet present and future QC needs and manages those resources to meet annual profit plan.
Supports the achievement of plant objectives (e.g., metrics, productivity, etc.).
Applies leadership principles to testing operations.
Performs other duties as assigned.