Job Information
Integra LifeSciences Batch Record Review in Columbia, Maryland
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SUMMARY
The Batch Record Reviewer will carry out manufacturing practices in a cGMP biotechnical facility. The job involves reviewing, training, coaching Tissue Processing Technicians on batch records requirements in the Raw Material Department, Sheet and MicroMatrix Cleanrooms, and Component Preparation. The batch record reviewer will be the interface between operations and the Quality control team. The Batch Record review may also perform the tasks required as a Tissue Processing Technician if required to support production.
SUPERVISION RECEIVED
Under direct supervision of Sr. Operation’s Manager
SUPERVISION EXERCISED
Tissue Processing Technician I, II and Lead
ESSENTIAL DUTIES AND RESPONSIBILITIES
Review Batch history records prior to being submitted for quality review
Provide feedback to Supervisor and Lead on:
Individual Tissue Processing Technician batch record performance
Recommend disciplinary action if required
Tissue Processing Technician Mid-year and Annual performance review input
May also perform duties of Tissue Processing Technician and Tissue Processing Technician II
Make suggestions that would improve the batch record review process or material processing
Keep track of the batch record review yield and work with engineering and the CI manager for process improvements.
Perform other tasks as needed
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Education & Experience:
High school diploma or equivalent
3 years GMP experience in an FDA regulated facility;
Required Knowledge, Skills, and Abilities
Good work ethic, dependable and punctual
Able to work well in both groups setting and independently
Flexible and adaptable to changing assignments
Working knowledge of GMP and ISO standards preferred
Must complete 90% of all training on the Tissue Processing Technician matrix
Satisfactory performance and performance reviews
Capable of leading and motivating Tissue Processing Technicians
TOOLS AND EQUIPMENT USED
Operation of specialty equipment (ex: lyophilizer, condenser, die press, etc.)
PHYSICAL REQUIREMENTS
Repetitive motion of wrists, arms, and hands
Lifting of up to 40 lbs.
Standing for two hours or more; sitting for two hours or more
Ability to properly apply and remove sterile gowning
Ability to work with raw materials (porcine bladders)
ADVERSE WORKING CONDITIONS
The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.
Clean room environment; must be able to properly gown and de-gown
Handling of raw materials (porcine bladder) required
May encounter strong odor of strong cleaning material
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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