1001 Durham Ave South Plainfield, NJ 07080 | 908.941.5456
QA Manager (PR)
Location: Dorado, Puerto Rico
The QA Manager is responsible of overseeing the Quality Assurance functions while ensuring compliance with regulatory agencies. This position is responsible as a Site Subject Matter Expert (SME) to provide Shop floor quality perspective review and approval, of in-line/offline manufacturing batch records associated to all manufacturing and packaging process and to directly overlook manufacturing activities to assure that these are performed within the framework of corporate/governmental policies and regulations (cGMP’s). Also responsible for plant wide review and approval of Quality Events investigations associated to site operations and Master Documents such as qualification/ validation protocols/reports. Is responsible for the development, implementation and enforcement of Quality Assurance systems and programs to enable the company to consistently satisfy its current/future product quality assurance requirements. Manages the establishment and improvement of quality assurance activities within the manufacturing and packaging areas to ensure product quality.
COMPETENCIES – To perform the job successfully, an individual should demonstrate the following competencies:
Conflict Management-Reads situations quickly & steps up to conflicts & settles disputes equitably. Good at focused listening. Can find common ground & get cooperation with minimum noise.
Action Oriented-Enjoys working hard. Is action oriented and full of energy for the things he/she sees as challenging. Not fearful of acting with a minimum of planning. Seizes more opportunities than others.
Planning-Accurately scopes out length and difficulty of tasks and projects. Sets objectives and goals. Breaks down work into the process steps. Develops schedules and task/people assignments. Anticipates and adjusts for problems and roadblocks. Measures performance against goals.
Directing Others-Is good at establishing clear directions, distributes the workload appropriately, brings out the best in people.
Decision Making- Makes decisions in a timely manner, sometimes under tight deadlines and pressure. Able to make a quick decision.
Problem Solving-Uses rigorous logic and methods to solve difficult problems with effective solutions. Probes all fruitful sources and looks beyond the obvious for answers. Can see hidden problems. Is excellent at honest analysis.
Business Acumen- Knows how businesses work. Knowledgeable in current & possible future policies, practices, trends, developments in his/her business.
Dealing with Ambiguity- Can comfortably handle risk and uncertainty. Can effectively cope with change and shift gears comfortably. Doesn’t have to finish things before moving on. Can decide and act without having the total picture.
Quality and Compliance- Adheres to standard operating procedures, defined practices & regulations. Attentive to detail & accuracy with optimal speed & volume. Committed to excellence & continuous improvement. Produces work that is right the first time, always with the customer in mind.
SUPERVISION – This position has supervisory responsibilities.
WORK CONDITIONS – Office environment. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Specific vision abilities required by this job include close vision and distance vision.
TRAINING AND EXPERIENCE:
Incumbent must have a broad knowledge on Quality Systems such as Change Control, Investigations and CAPA’s. Must be fully bilingual in both English and Spanish, with strong, thorough, and concise written and verbal communications skills and above average computer literacy (MS-Office). Broad knowledge of relevant governmental regulations, cGMPs and guidelines. Solid technical writing skills related to investigation reports. Ability to create / organize cGMP systems procedures based on regulatory / compliance requirements. Incumbent must possess strong mathematical skills. Excellent technical writing skills are required.
To learn more about PuraCap Pharmaceutical, visit http://puracap.com/
To apply for this position, email your resume and a cover letter to humanresources@PuraCap.com
Not only is PuraCap an internationally inclusive company, but we embrace and encourage diversity. PuraCap is proud to be an equal opportunity workplace and is an affirmative action employer.