Quality Assurance Manager

Location
Kalamazoo, Michigan
Salary
Competitive Salary + benefits
Posted
Dec 09, 2018
Closes
Feb 07, 2019
Field of specialization
Pharmaceutical
Job Type
Full time

Job Description:
Kalexsyn is currently seeking a highly motivated and team‐oriented candidate for the position of Quality
Assurance Manager. The successful candidate will be responsible for defining Quality Management
Systems, ensuring that manufacturing activities for the production of pharmaceuticals for human use are
consistent with applicable GxP regulations and company policies. The successful candidate will be able to
work with minimal supervision within a supportive team environment.
Qualifications:
 Bachelor's degree in a scientific field required, higher degree preferred.
 Five year’s experience in a QA/QC laboratory required.
 Extensive knowledge of GxP regulations and SOP implementation required.
 Experience in change management systems is preferred.
 Experience with software programs such as Office, LIMS, SAP required.
 Strong attention to detail, organization, time management, communication, and interpersonal skills
are required.
Responsibilities:
 Ensure that the facility’s organization and procedures meet all applicable GMP requirements.
 Review documentation for the release of all production materials and final APIs.
 Implement, maintain, and monitor a training system that ensures all personnel are appropriately
trained.
 Issue Standard Operating Procedures (SOPs) related to the facility’s activities.
 Approve the operating instructions (Master Batch Records) related to the manufacture of products
and guarantee revision of related documents.
 Define and approve material and product specifications in collaboration with QC.
 Ensure that Product Quality Reviews for all products are generated, reviewed, and approved.
 Ensure that necessary qualifications / validations are carried out.
 Implement a Plant Validation Master Plan and approve Protocols and Reports of qualification /
validation.
 Establish stability protocols and ensure that stability data supports product re‐test and storage
conditions.
 Ensure that any non‐conformance with procedures or cGMP is investigated, documented, properly
reported and resolved according to the appropriate incident management tool.
 Manage the change control system.
 Ensure that self‐inspections are performed at appropriate regular intervals.
 Manage qualification of suppliers and contractors.
 Ensure maintenance and calibration procedures and checks of critical equipment are performed
and effective.
 Other duties as assigned.

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