Friday, September 5, 2014

Director Mgr Quality and Regulatory Affairs



- Responsible for the development, implementation, and management of the
company's Quality Systems to ensure compliance with GMP's with respect to
the manufacturing, quality control, holding, and distribution of products.
Compliance with GMP's includes the implementation and maintenance of a
document control system, an employee training program, and equipment
qualification program, product testing program, stability program,
validation program and internal audit program.

- Maintain all local, state, and federal licenses, permits and
registrations as well as third-party GMP accreditations.

- Primary responsible person for managing audits by outside firms or
agencies.

- Comprehensive understanding of FDA 21 CFR Parts 111, 210, 211, and 820.

- Communicate with business partners, manufacturers and raw material
suppliers regarding all Quality and Regulatory matters.

- Coordinate the gathering of information and generation of responses
related to product formulation and product quality questions.

- Review and approve product labeling.

- Prepare Certificates of Analysis and Certificates of Manufacture for
product exports.

- Write and approve SOPs, Protocols, and forms/templates.

- Assure that the CAPA system is effective and current.

- Establish appropriate release standards, and review and approve release
data for products and other materials.

- Issue, write, and approve Batch Production Records.

- Prepare CAPA, Deviations, Lab Investigations, Adverse Event, Product
Complaint responses, and applicable annual reports.

- Coordinate the gathering of product information needed for product
certification in countries outside the US.

- Plan, direct and manage QC laboratory activities, which includes setting
priorities for lab personnel and providing technical support and guidance,
to ensure all QC laboratory testing is performed per specifications and in
a timely manner.


- Responsible for maintaining lab equipment calibration and maintenance
program, renewal of yearly service contracts and ordering supplies for
smooth and efficient QC laboratory operation.

- Help to improve business results by using analytical tools and systems to
reduce/eliminate manufacturing defects and non-conforming products as well
as investigating lab related failures and deviations to increase efficiency
and reduce overall costs.

- Provide technical guidance and problem-solving methodologies regarding
lab-related issues.

Education and Experience:

- Bachelor Degree (preferably in Life Sciences)

- 5 or more years related experience and/or training

- Must have experience in the food/supplement/pharmaceutical industry and
must have working knowledge of: Product formulations, Product standards,
labeling standards, quality control procedures and GMPs

Required Skills:

- Demonstrate strong leadership skills and the ability to lead others in a
cross-functional team

- Demonstrate ability to coordinate the execution of multiple projects in a
fast paced environment

- Must exhibit good communication and facilitation skills, both oral and
written

- Broad scientific knowledge, especially in chemistry and microbiology

- Excellent interpersonal and problem solving skills in dynamic environment

- Ability to manage multiple priorities to implement projects in a timely
fashion

- Knowledge of appropriate cGMPs, FDA regulations and guidelines

- Excellent organizational skills

- Computer literacy, especially with the Microsoft Office Suite of products

Additional:

- Minimum experience would be 5 years for Manager and 7 years for Director

- Pay could range from $60K - $100K based on candidate and whether they are
hired at Manager or Director level


- Will have 7 direct reports - 4 in QC and 3 in QA

- Travel is approximately 10% and would include vendor site audits and
annual trade show

- Monday - Friday; 8:00am - 5:00pm or 9:00am - 6:00pm

About Aerotek Scientific:

Aerotek, headquartered in Hanover, Md., is a leading provider of technical,
professional and industrial staffing services. Established in 1983, Aerotek
is an operating company of Allegis Group, the largest provider of staffing
services in the U.S. Aerotek operates a network of more than 200
non-franchised offices throughout the U.S., Canada and Europe. For more
information, visit Aerotek.com.

Christian McDuffey

cmcduffe@aerotek.com

Aerotek Scientific - Dallas, TX
433 E. Las Colinas Blvd
Suite 350
Irving, TX 75039
TEL: (214) 414-2482