Manager, QC Systems and Services - Memphis, TN | Biospace
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Manager, QC Systems and Services

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, Manager, QC, Quality, Quality Control, Regulatory, Software,

Job Description

Cognate BioServices is currently seeking a Manager for our Quality Control department. The successful candidate will be an energetic individual responsible for developing, implementing and managing the kick-off and operation of a new division within the QC department, focused on QC systems and services. This will include screening and hiring of new team members to establish and fill out the group and ensure clockwork-like functioning.

The position requires the utmost attention to detail, exemplary 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. Key attributes include a working knowledge of cGMP documentation requirements, experience with analytical QC/QA and QC departmental organization/flow, compliance auditing, LIMS functioning and management, product trending and metrics experience, and final product release package compilation and sign-off. A summary of the envisioned Services and Systems to be overseen by the Manager is outlined below:

Services:
-   Requests, accessions, stores, monitors and tracks all incoming and outgoing QC test samples
-   Ships product samples required for subcontracted testing including correspondence with subcontractors regarding expected off test and report dates.
-   Issues test samples and update inventories as required.
-   Issues retains with appropriate request and authorization
-   Sample/Retain inventory maintenance and periodic auditing
-   LIMS interface development and implementation in conjunction with LIMS Project Manager
-   LIMS training of other QC employees
-   LIMS maintenance (QC only)

Systems:
?   In collaboration with Quality Assurance, reviews, revises and develops department-wide QC operational specifications, test methods, P&Ps, SOPs, SWIs, and job aids governing how QC functions in full compliance with GMP.
?   Audits QC to ensure internal compliance with documents and cGMP.
?   Receives and reviews results from QC Analytical and Micro/EM groups for completeness and accuracy. Approves final results.
?   Gathers results for QA metrics.
?   Corrects errors in QC documentation in compliance with GDP.
?   Prepares and organizes analytical test result documentation and compiles into completed product release package for submission to QA ensuring all documentation is complete and complies with GDP.
?   Enters product analytical test results into trending spreadsheets/files, where applicable (gathering for QA metrics reporting quarterly).
?   Submits completed packages to QA and rectifies any documentation errors discovered and returned by QA.
?   Works closely with Analytical and QA groups to stay apprised of changes to assays, deviation, CAPA, OOS or other procedures or documentation requests from QA.
?   Works with incoming raw materials QC to obtain material CoA required for and included with product batch release.
?   Reviews required initial and continuing training of department personnel to ensure compliance.
?   Archival/filing of older documentation
?   Stays current with US and EU regulatory guidance’s (CFR, USP, EP, Eudralex, ICH, OSHA).


ESSENTIAL DUTIES/RESPONSIBILITIES
•   Oversee and establish work roles within the departmental hierarchy (supervisor, analyst, etc)
•   Review and revise Cognate’s current QC flow to integrate these new functions (listed above) and transition some existing functions from analytic laboratory staff to new S&S staff.
•   Work closely with QA and the QC Director to ensure QC maintains cGMP compliance
•   Perform critical review of QC operations with the aim of streamlining and improving compliance and function
•   Revise and/or establish new department-wide operational procedures, as needed
•   Oversee receipt, tracking and issuance of all QC samples and retains by staff members
•   Oversee the review of analytical results for completeness/accuracy in preparation for submission to QA
•   Monitor performance of quality control systems to ensure effectiveness and efficiency
•   Identify quality problems or areas for improvement and proactively recommend solutions
•   Stays abreast of relevant changes in key regulatory guidances (USP, EP, Eudralex, CFR, ICH, etc)
•   Provide site leadership by developing and empowering staff, putting staff in a position to succeed by meeting their personal career goals while also achieving organizational goals,
•   Build an effective team that applies their diverse skills and perspectives to achieve common goals, driving engagement and creating a climate where staff are motivated to do their best
•   Maintains

Requirements

QUALIFICATIONS
•   BS or higher degree in the biological science or related field
•   Minimum of 5 years of experience in QC systems management
•   Proficient in use of MS Office
•   Strong leadership attributes
•   Experience with MasterControl required
•   Experience with Labvantage or other LIMS system a plus
•   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 advanced 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.