Senior Associate II, Quality Assurance (Quality Engineering)

Biogen Idec Research Triangle Park , NC 27709

Posted 2 months ago

Job Description:

The Sr. Associate II responsibilities will ensure that Quality systems supporting facility, equipment, automation and utilities within the Quality Assurance department remain in compliance with Biogen and industry cGMP standards.

Responsibilities include, but are not limited to:

  • Review of GMP raw data and GMP documentation for compliance to applicable procedures as well as regulatory and corporate guidance documents, review of validation protocols (equipment, cleaning, and automation), review/approval of GMP procedures, instrument & controls oversight, and support of investigations impacting the utilities, equipment and RTP site.

  • The position will assist in the development and implementation of Global Quality Systems, leading site and global initiatives, identify gaps in existing Quality systems and propose solutions to site management.

  • Provides oversight with respect to proper adherence to all regulatory licenses and regulations

  • Collaboratively interface with key Quality, Manufacturing, and Engineering customers to achieve site and company objectives

  • Support internal compliance audits; external inspections from regulating agencies, assess and approve discrepancies from site, corporate, and regulatory guidance.

  • Support the Manager for activities related to interviewing, hiring and training of employees, as well as compliance with training policies.

  • Ensure oversight and completion of all departmental milestones associated with clinical and commercial product manufacture.

Principal Accountabilities supporting Drug Substance & Drug Product site:

  • Oversight of the Change Control program at the Drug Substance & Drug Product campuses ensuring that the overall program health and metrics are maintained.

  • Develops and implements aspects of various Quality Systems/System Improvements, specifically Change Management.

  • Lead strategic Quality initiatives cross functionally and globally

  • Facility, Utility, Equipment and Automation Validation review/approval of procedures, protocol/report approval.

  • Oversight of facility and equipment controls and release during shutdown, construction, product changeover.

  • Provide cGMP guidance and quality support for Manufacturing Engineering and Automation on the floor issues, including assistance with deviation initiation and investigation.

  • Review of PM work orders and CM work orders as applicable to cGMP systems

  • Proactive identification and resolution of both technical and compliance issues/gaps

  • Performs QA review of alarm assessments for cGMP equipment

  • LI-POT6

Qualifications
10+ years of Quality / Industry-related experience in the following disciplines:

  • Robust experience with Change Control program management

  • Subject matter expert for change management, Quality Risk Management and data integrity

  • GMP review of validation documentation and strong knowledge of equipment/facilities/utility /automation systems

  • Technical expertise in bulk drug substance biologics production or sterile parenteral & biologics fill/finish and visual inspection operations

  • Agency inspection experience

  • Previous experience with Quality Systems development

  • Knowledge of current global Regulatory Quality requirements

Education

Bachelor's Degree in Engineering or related Life Science or Technical discipline


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Quality Systems Specialist II

BD (Becton, Dickinson And Company)

Posted 3 days ago

VIEW JOBS 11/16/2018 12:00:00 AM 2019-02-14T00:00 Job Description SummaryThis position will function within the Quality Assurance Unit of Corporate Preclinical Development & Toxicology (CPDT) and will participate in the conduct of nonclinical laboratory investigations of medical devices and materials in accordance with GLP regulations and the BD CPDT Quality System. Quality Assurance strives to live BD values as part of an action-oriented team focusing on customer requirements and process effectiveness through continuous learning, influencing of others, and dedication to achieving the highest quality results. The Quality Systems Specialist II is accountable for support of the continued development, improvement and implementation of the Quality Systems. This position actively participates in quality guidance, product resolution decisions and problem solving techniques to promote New Product Development and provide support to project teams for process improvement and continuous improvement activities. Job Description Primary Responsibilities and Duties: * Responsible for utilizing and developing phase and systems audit programs for internal laboratory functions and external suppliers in direct support of 21 CFR Part 58 and the overall Quality System. Quality Assurance Unit documentation/activity support applies to most aspects of the systems employed by BD CPDT for material risk assessments, material characterization, and internal/external GLP biocompatibility testing for medical devices as described in ISO 10993 and FDA G95-1. * Operate the BD CPDT Document Control system for all controlled documents including but not limited to Policies, Protocols, Reports and Standard Operating Procedures. * Support the BD CPDT Training System to ensure training is performed and documented in order to maintain compliance to Quality System and regulatory requirements. * Active Participation in the development, implementation and maintenance of various aspects of the BD CPDT Quality System including creating and reviewing documents (SOPs, Procedures, Methods, Protocols) in overall support of continual quality improvement. * Accompany representatives from sponsoring organizations or government regulatory agencies during site audits. * Responsible for GLP and Quality System training. * Responsible for maintenance of the Master Schedule. * Serve as backup for the BD CPDT GLP Archives for all controlled records, documents and samples. * Assist with Metrology program including maintenance of Regulatory Asset Manager System. * Assist in management of the supplier audit and approval system, including setting audit dates with suppliers and performing audits. * Collaborate with managers, scientists and Quality Assurance personnel to develop process improvements in order to enhance testing and workflow efficiency. * Maintain an environment of continuous improvement and quality aligned with BD core values and strategic objectives. KSA Requirements (Knowledge, Skills, and Abilities): Education/Experience: * Typically requires a minimum of a Bachelor's Degree in a scientific discipline. * A minimum of 2 years relevant experience or a combination of equivalent education and relevant experience. Knowledge: * Moderate level of application of Quality System Standards to assigned Quality system area. * Working Knowledge of Quality Systems Regulatory requirements and application to Company/Unit requirements Skills: * Demonstrated ability to work successfully independently as well as part of a team. * Excellent verbal and written communication skills. * Must have the ability to focus and to execute multiple projects and programs simultaneously while maintaining attention to detail. * This position requires excellent organizational and the ability to adapt rapidly to changing priorities in a high volume scientific testing laboratory. #LI-OPS Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status. Primary Work LocationUSA NC - Research Triangle Park Additional Locations Work Shift BD (Becton, Dickinson And Company) Research Triangle Park NC

Senior Associate II, Quality Assurance (Quality Engineering)

Biogen Idec