Senior Quality Assurance Manager / Area Director

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POST DATE 9/2/2016
END DATE 12/19/2016

Thermo Fisher Scientific Rockville, MD

Rockville, MD
AJE Ref #
Job Classification
Full Time
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Quality Assurance Sr. Manager/Area Director
Key Responsibilities:

* Support all staff in Quality Control/ Quality Assurance to ensure ongoing compliance.
* Manage and support remote Quality Assurance team.
* Training, coaching and mentoring team members to achieve their potential.
* Provide input on performance reviews for all staff within the functional area supervised.
* Manage Continuous Improvement Activities: Drive functional strategy, the creation, update and consolidation of necessary SOPs, change control and collection of data or measurement of critical compliance values as part of the Fisher BioServices continuous improvement plan.
* Responsible for implementation and execution of BioServices QA Plan.
* Trend and provide QA metrics to detect any recurring quality issues.
* Review Operational and validation records such as validations, calibrations, and reports as necessary.
* Ensure that quality documents, protocols, methods, material records are current, accurate and properly utilized.
* Conduct internal audits.
* Conduct document review for both Commercial and Government operations.
* Review and approve BioServices change controls.
* Management of supplier/vendor program.
* Conduct supplier/vendor audits
* Management of training program.
* Management of mock recall process.
* Conduct Management Review as applicable.
* Performs other duties as assigned by his/her supervisor.

Minimum Requirements/Qualifications* :*
Education/Training** :

* Bachelor's Degree in Scientific/Technical field (i.e. Chemistry, Biology, or Engineering).
* Master's Degree, preferred
* Knowledge of the pharmaceutical GMP regulations and their appropriate application is needed to assure compliance with regards to manufacturing problems

Business Experience* :

* A minimum of 3-5 years of supervisory experience in a GMP or similarly regulated facility.
* A minimum of 3-5 years cGMP hands-on experience in Quality
* Requires thorough knowledge of cGMPs for medical devices or pharmaceuticals.
* Knowledge of software compliance (21CFR; Part 11)


* Proficient with personal computer skills, specifically Microsoft office applications, with the ability to learn new computer systems quickly.
* Effective communication skills are required, both written and verbal.
* Problem solving skills are required in situations that are not procedurally managed.
* Extremely adept in attention to detail/follow up.
* Excellent interpersonal skills, problem solving skills, planning/organization skills, strategy and customer focus.
* Ability to handle multiple tasks while ensuring timely and accurate completion.
* Ability to work independently

Working Conditions**

* Environment (Office, warehouse, etc.) -__ office and sometimes warehouse, repository or laboratory

Physical Requirements (Lifting, standing, etc.) -__ Use of computer for 2-4 hours per day. Must be able to work fully gowned in laboratory coat, hair cover, facemask, and gloves for up to 2 hours per day. Must be able to walk for up to 4 hours per day. Some out of town travel may be required. Participation in the Hepatitis B vaccination program is recommended.
Non-Negotiable Hiring Criteria** : (List 3-5 key attributes, skills, or requirements that the candidate must have to be considered for this position)

* Bachelor's Degree in Scientific/Technical field or equivalent
* 3-5 years cGMP experience
* Ability to work independently and handle multiple tasks while ensuring timely and accurate completion