Quality Assurance Specialist II

Advanced BioScience Laboratories (ABL) is a biotech corporation with headquarters located in Rockville, MD providing contract manufacturing and laboratory research services to advance leading vaccines and therapies from clinical development to the commercial market. ABL has been around for nearly 60 years, has three locations (one domestic and two in Europe), and is part of the Institut Mérieux family.

ABL harnesses decades of pioneering science and manufacturing expertise to drive the development of innovative therapies and vaccines supporting the biopharmaceutical industry in their quest to improve public health. Come join us in empowering people to conquer the world’s most challenging diseases.

This position will operate out of our Rockville, MD office. Due to the nature of this position, much of the work will be performed onsite - some work from home options are available.

A great candidate will have GMP quality experience, having some client-facing experience, have a can-do, roll-up your sleeves approach to work, be collaborative with QA as well as the other departments, and be agile.

The main responsibilities will include but not limited to follows:

• Critically review, approve and issue various GMP documentation to ensure completeness, accuracy, and compliance; including but not limited to: Manufacturing records, Quality Control Environmental Monitoring data, batch and material release, specifications, SOPs, test method, GMP analytical and bioanalytical data, product labels, alarm reports, deviation investigations, CAPAs and change controls.

• Critically review Quality related documents and procedures from ABL Rockville subcontractors.

• Ensure analytical methods are qualified/validated appropriately in accordance with ICH guidelines.

• Support Room, Product and Raw Material Release.

• Provide QA representation on client projects meetings and interact with clients or subcontractor QA personnel and provide feedback on on-going activities, when needed.

• Review client provided documents to meet ABL Rockville policies for entire product life cycle (release, receipt, manufacturing and shipment etc.).

• Participate in ABL Rockville audit program including internal, client and supplier activities and serve as subject matter expert in quality assurance operations.

• Provide and assist in training other team members.

• Comply, review and provide feedback on Quality Systems and associated reports including but not limited to Deviations, CAPAs, Change Control, Quality Risk Assessment and Management Review in support of ABL Rockville and ABL subcontractor manufacturing operations.

• Lead or participate in cross-functional teams to address facility issues using methodical problem solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact to product.?

• Suggest improvement to ABL cGMP activities and Quality System policies and provide expertise and troubleshooting for all Quality related concerns.

• Report quality deficiencies to Supervisor and Department Heads.?

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

• Other duties as assigned.

JOB REQUIREMENTS

• Bachelors of Science Degree in Biology, Chemistry, Engineering, or related fields.

• A Minimum of 6 years of experience within the life sciences industry, preferably biologics or vaccines, with at least 4 of those years in a Quality Assurance role.

• Lean/Six Sigma experience, or equivalent certification/education/experience is preferred.

• Prior experience with US and EU pharmaceutical regulations.

• Clear knowledge and application of cGMP principles, and working in an FDA / EMA regulated environment.

• Experience with cGMP of biologics, manufacturing of proteins, vaccine manufacturing for preclinical and clinical drug development programs.

• Knowledge of cell banking, cell culture, and downstream purification processes.

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

• Able to be flexible to changing priorities, the ability to organize and deliver tasks & projects with a sense of urgency under minimal supervision without neglecting attention to detail.

• Ability to work under pressure, analyze processes within scheduled timeframes, and manage multiple projects simultaneously. Able to work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.

• Excellent communication skills: oral, written and listening. Excellent computer skills; strong knowledge of MS Office, Excel, Word, Power Point, Outlook, Visio.

• Employment is contingent upon favorable background, reference and physical to include drug screen as determined by our Occupational Health Consultants.

• Must be able to lift up to 20 lbs with or without reasonable accommodations.

Why Work With ABL?

ABL offers good benefits, flexibility, a generous PTO and 401k match and contribution, tuition assistance, wellness program, and referral program (visit our website to see more!). We have deep roots and are working on many changes to improve and expand our service to our customer. There are opportunities to get involved and create!

ABL, Inc. does not accept nor respond to unsolicited resumes from vendors, including recruitment agencies and search firms. Approved recruiting agencies must obtain prior approval from ABL, Inc. Human Resources in order to submit resumes to ABL, Inc. for consideration.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• GMP (life sciences - biologics): 3 years (Preferred)
• QA: 3 years (Required)

Work Location:

• One location

Work Remotely:

• No

Work Location: One location