QC Manager (PR)

Location: Dorado, Puerto Rico

Position Summary

The QC Manager is responsible of overseeing Quality Control laboratories functions while ensuring compliance with Regulatory Agencies. Is responsible for the development, implementation and enforcement of Quality Control Systems and programs to enable the company to consistently satisfy its current/future product quality analytical requirements. Manages the establishment and improvement of quality control activities within the laboratory and sampling areas to ensure product quality.

KEY RESPONSIBILITIES:

1. Accountable for the establishment of all objectives, strategies and action plans embodied in laboratory services.
2. Responsible for all quality control programs, control, monitor and reduce the cost of quality while ensuring high quality standards are met.
3. Ensure laboratory compliance with regulatory governmental agencies through systems and controls.
4. Provide technical expertise to support the development of QC testing methods and material specifications for products to be manufactured by the division.
5. Establish and manage the QC Department organizational structure to facilitate plan accomplishment both short and long term.
6. Ensure the preparation of specifications for purchase of laboratory equipment, supplies and materials to meet testing schedules and quality standards.
7. Manage and maintain a safe working environment within the department, including the safe and effective handling of dangerous goods and substances.
8. Act as a scientific and technical representative and liaison for the Division with respect to technical matters and client maintenance on a timely basis.
9. Conduct and maintain stability programs for new and on-going products.
10. Conduct and maintain Site’s Environmental Monitoring Program.
11. Prepare department budget and control expenses within approved amounts.
12. Provide technical advice and assistance to other laboratory personnel in laboratory investigations, assure investigations are close according established procedures and corrective and preventive actions are implemented.
13. Responsible for accurate analytical work to determinate product quality.
14. Carry out other duties as assigned that are deemed reasonable and within the broad scope of the position.

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:

•      Education:

BS Chemistry or chemistry related sciences

•      Training:

In-depth knowledge of international requirements of cGMP’s and cGLP’s.

•      Previous experience:

Minimum of five (5) years managerial experience in the pharmaceutical industry in QC. – QA area.  Exposure to a regulatory affairs environment.

•      Certificates, Licenses or Registrations:

Chemistry License required.

SKILLS:

Incumbent must be fully bilingual in both English and Spanish, with a strong, thorough, and concise written and verbal communications skills and above average computer literacy (MS-Office).   Incumbent must possess strong mathematical skills.  Excellent technical writing skills are required.

The incumbent must be able to work in a team-based matrix environment.

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.