Summary Assists in establishing quality systems as they pertain to current industry, regulatory and customer requirements. Also assists the QA Asst. Director/ VP Quality Operations in maintaining the established systems. Provides quality assurance project support for cGMP operations.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Assists in review of batch records and corresponding documentation prior to product disposition
Distributes and tracks controlled copies of batch operating procedures (BOP) for manufacturing campaigns
Assists and manage in establishing Standard Operating Procedures (SOP)
Issues, tracks and controls laboratory log sheets for all scientific personnel.
Assists in routine maintenance of SOPs, including periodic reviews
Reviews shipping documents prior to all shipments of product
Maintains up-to-date raw material specifications and issues controlled copies to purchasing and Quality Control.
Issues deviation report numbers, out of specification (OOS) numbers, Corrective Action Report (CAR) numbers and change control.
Assists in preparation for customer visits prior to audits and collecting documents during audits for review by the auditor or investigator.
Reviews QC analytical results to assure that material meets specifications and releases/rejects as dictated by findings.
Maintains training records and training record program, updating as necessary, for all personnel.
Assigns SOP, Batch Record, validation, protocol, cleaning, investigation and change control numbers. Ensures documents are received and filed in a timely manner.
Performs raw material review and disposition, in addition to maintaining computer system.
Maintains raw material vendor relationships, i.e. creating specs and obtaining of C of A.
Reviews and releases final products
Assists in maintaining compliance status of the facility
Effectively communicates with management.
Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience
Prefer BS degree is Chemistry, Biology or related scientific discipline; will consider Associate's Degree (AA/AS) with two – four years relevant experience. Previous Pharmaceutical or cGMP experience preferred (Required for Quality Specialist II).
Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
To perform this job successfully, an individual should have knowledge of Database/spreadsheet software; presentation software and Word Processing software.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to sit. The employee is occasionally required to walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles. The noise level in the work environment is usually quiet.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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