QC Supervisor, Incoming Raw Materials Testing - Memphis, TN | Biospace
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QC Supervisor, Incoming Raw Materials Testing

Cognate BioServices, Inc.

Location:
Memphis, TN
Posted Date:
7/24/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biotechnology, Compliance, Materials/Inventory Control, QC, Quality, Quality Control, Supply Chain,

Job Description

Cognate BioServices is currently seeking a Supervisor for a new raw material testing/release division of our Quality Control department. The successful candidate will play a lead role in establishing and implementing procedures for organizing and ensuring the successful performance of sampling, testing (subcontracted or in-house) and release of all incoming raw materials which will be used in GMP manufacturing of cell-based therapies. At its core, this includes review of critical raw material attributes, determination of appropriate (risk-based) testing required in collaboration with technical staff, establishing material sampling/retain plans based on prevailing guidance’s (e.g. ANSI), management of logistics and tracking associated with timely shipment of samples to subcontractors for testing with results follow-up and the hiring of additional staff to accomplish all the above. This individual will serve to establish the foundation of this program and, in close collaboration with QC and Quality Assurance, build it from the ground up.
The position requires the utmost attention to detail, very strong organizational skills, and computer proficiency. In addition, effective communication skills and the ability to function in a fast-paced, highly technical environment with minimal supervision are essential for success.
ESSENTIAL DUTIES/RESPONSIBILITIES
•   Responsible for the oversight/execution of inspection, testing and release of all raw materials for GMP production
•   Develop material sampling plans for testing and retain of identified critical raw materials
•   Accession, store, track, inventory and control sampled materials and retains
•   Participate in subcontractor test lab qualification, as required
•   Coordinate logistics associated with sending samples to subcontractors for testing as well as any in-house testing
•   Monitor in-house and subcontractor testing progress
•   Compile, review and approve test results from in-house and subcontractor labs for release of raw materials
•   Identify and establish relationships with new subcontractors, as required, to support testing not performed in-house
•   Ensure materials are sampled and tested on time and in accordance to documented procedures
•   Author and maintain work instructions, test methods, policy and procedures, and standard operating procedures (SOP), as appropriate
•   Maintain adequate inventories of sampling, testing and release supplies
•   Initiate and assist QA in raw material out-of-specification investigations
•   Train new hires on department processes, procedures and tools including OSHA compliance and laboratory safety
•   Adhere to good documentation practices and drive any open deviations, CAPAs, OOS’s or similar to closure
•   Other duties as required

Requirements

QUALIFICATIONS
•   Minimum of four (4) years in raw materials sampling or similar experience
•   Strong knowledge of GMP, ICH and EU regulations applicable to raw materials used in GMP manufacturing
•   Knowledge of raw materials sampling techniques and of sampling plans
•   Knowledge of GMP regulations in a cGMP environment
•   BS or higher degree in the biological science or related field
•   Experience with supply chain logistics and material release processes is required
•   Highly collaborative with the proven ability to work in a cross-functional team
•   Detail-oriented with strong written and verbal communication skills
•   Ability to problem-solve and troubleshoot as necessary
About Cognate
Cognate is a dynamic organization focused on providing a broad range of commercialization services to regenerative medicine and advance cell therapy organizations. Cognate provides specialized services to companies across all points of clinical and commercial development ranging from early preclinical studies through commercial manufacturing. Cognate applies the expertise of its business, scientific and technical teams to successfully develop biotechnology products across multiple cell-based technology platforms from start to finish.

Employees are our most valuable resource. We are committed to fostering an environment where innovation, teamwork, communication, and recognition are encouraged and rewarded. Cognate offers a competitive base salary, tuition reimbursement, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, prescription, FSA, short/long term disability, life, voluntary life and 401(k). Cognate is an equal opportunity employer that values diversity at all levels.