Quality Assurance Specialist

Advanced BioScience Laboratories, Inc. (ABL), a contract research and manufacturing organization located in Rockville, Maryland has over 50 years of experience as a fully integrated service provider for commercial, government, and academic clients in the biopharmaceutical industry.  Our expertise - the development of vaccines and protein-based therapies provides critical support to help our clients achieve their preclinical and clinical goals.  

We are looking for an experienced and motivated Quality Assurance professional, reporting directly to the QA Manager, to provide QA support and expertise in support of Quality compliance for internal and external GMP projects.   The successful candidate will contribute to the team in support of preparation of and review of quality related documents and provide feedback to QA Management team members and to the manufacturing and other departments. The candidate will suggest and implement quality improvements efforts to the Quality System. Candidates successful in this position would be able to: 

PRIMARY JOB FUNCTIONS:

•  Review documents from Quality Assurance perspective provide feedback to Manufacturing, facilities, Quality Control and IT.

•  Makes recommendations on cGMP activities and Quality System policies.

•  Interact and plan workload with Supervisor and other Department personnel.

•  Interact with Client’s QA personnel and provide feedback on on-going activities, when needed.

•  Provide expertise and troubleshooting for all in-house Quality related concerns.

•  Review client provided documents to meet ABL policies for product receipt, manufacturing and shipment.

•  Ensure that the equipment maintenance and calibration program is effective.

•  Ensure raw materials, intermediate products and final products are appropriately released.

•  Perform internal audits.

•  Issue quality documents such as batch records, test methods, product labels and other documents to respective departments

•  Review completed batch records and laboratory records for product release. 

•  Review Environmental monitoring data; review investigation and protocol reports and product specs.

•  Accurately follows written procedures and performs review of all records and associated data to release products manufactured by ABL

    to meet product supply schedules, including completion of checklists, Certificates of Analysis or Conformance.

•  Responsible for continuous improvements to the ABL Facility and Quality Systems.

•  Provides guidance and training to ABL staff regarding GMP compliance.

•  Reports quality deficiencies to Supervisors and Department Heads.

KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB:

• B.S. in Sciences or related scientific field or discipline.

• Equivalent direct experience may also be considered as a substitute for formal education.

• Minimum of 3-4 years experience in a technical/administrative field related to the industry.

• Experience in a GMP environment is a MUST to be successful in this position. 

• Previous experience in a CMO or CRO is a plus.

• Ability to concurrently manage multiple projects.

• The person in this position is expected to possess a clear understanding of the principles of Good Manufacturing Practices, FDA regulation and Quality compliance requirements related to biologic production.

• Excellent interpersonal skills both written and oral presentations.

• Must be a team player and able to interact with all echelons of ABL and staff and Management.

• Excellent computer skills; strong knowledge of MS Office, Excel, Word, Power Point, Outlook.

• Must meet pre-employment physical requirements to include drug screen as determined by our Occupational Health Consultants.

• Salary is commensurate with background and experience in the range of $50K - $65K.

• Candidates are encouraged to submit a cover letter outlining their background and experience as it relates to the position along with a resume and salary history/requirements.

Advanced BioScience Laboratories, Inc, is committed to providing a career that is both personally and professionally rewarding.  We offer an energetic and team-oriented environment as well as a competitive benefits and compensation package. ABL is an Affirmative Action Equal Opportunity Employer. M/F/D/V.