Quality Assurance Manager

Pisgah Labs is an FDA inspected Active Pharmaceutical Ingredient (API) manufacturer in Pisgah Forest, North Carolina that is currently seeking to fill an open role as a Quality Assurance (QA) Manager. Job Description Summary The QA Manager ensures facility-wide CGMP compliance to ensure that the final product observes Pisgah Lab's quality standards. They are responsible for the development and implementation of regulatory and client inspection activities, the detection and resolution of problems relating to production and quality control as well as the delivery of satisfactory quality outcomes. The QA Manager will also be responsible for the implementation and maintenance of Quality Management Systems (QMS) inclusive of documentation, etc. Essential Functions Primary Quality Representative for the facility. Supervision of Quality Assurance department Assure ongoing compliance with quality and industry regulatory requirements Responsible for quality management systems Develop and implement CGMP quality assurance policies and procedures Interpret and implement GMP quality assurance standards Evaluate adequacy of current quality assurance standards Review the implementation and efficiency of quality and inspection systems Monitor testing and inspection of materials and products to ensure finished product quality Management of site audits performed by customers and regulatory entities Document internal audits and other quality assurance activities Coordinate and support on-site GMP audits conducted by external providers Evaluate audit findings and implement appropriate corrective actions Investigate customer complaints and non-conformance issues Monitor risk management activities Collect and compile statistical quality data Analyze data to identify areas for improvement in the quality system Develop, recommend and monitor corrective and preventive actions Prepare reports to communicate outcomes of quality activities Identify training needs and organize training interventions to meet quality standards Qualifications Experience working in a heavily regulated environment, with intimate knowledge of CGMP regulations and compliance in a pharmaceutical manufacturing facility Ideally possesses working knowledge of analytical chemistry and statistical analysis Experience at assembling CMC sections / Module 3 for US DMFs Experience hosting FDA audits, investigations and related FDA administrative activities Familiarity with technology transfer, qualifications and validations Outstanding people skills for facilitating quality diplomacy and knowledge throughout the organization (locally), with clients / customers, and interfacing with the global organization. Possesses an enhanced attention to detail or focus for quality related matters Realizes timeliness is of the essence. Excellent verbal and written skills Maintains a systematic and consistent Quality System useable / meaningful to all employees Has significant industry interactions allowing for evaluation of FDA's "current thinking" Effectively integrates a multi-purpose plant for early stage work as well as commercial (generic) offerings Supervisory Responsibilities This position will supervise a small team in the QA department. Candidate will be responsible for developing the direction of the team and assessing outcomes and goals. The candidate will also be responsible for providing in-depth assessment of the QA department and team members at yearly evaluations and reviews. Work Environment This job is performed in an office setting with exposure to a manufacturing facility. The candidate will be exposed to normal office conditions and equipment that include computers, phones, printers, filing cabinets and other office accoutrements. The candidate will also be exposed to a pharmaceutical manufacturing environment that includes lab equipment, chemicals, large machinery, and other manufacturing accoutrements. Depending on location within the site, the candidate could be exposed to loud noise, though this will not be common. Physical Demands The work requires light physical exertion. The employee may be required to perform handling activities with lightweight or easily moved items (e.g. books, file folders, boxes of office supplies, small machine parts, etc.); perform moving activities for brief periods; operate light equipment; perform repetitive motions for brief periods; confined to a work area. Depending on the location that the candidate is in, proper use of personal protective equipment will be required. Position Type/ Expected Hours of Work This is a salary-exempt, full-time position. Flexible scheduling will be required and availability for days, nights and weekends as needed. Travel Possible overnight travel is anticipated for this position. Some occasional local day travel may be necessary. Education/Experience Master's degree preferred Pharmaceutical manufacturing experience required Certifications will afford the candidate an advantage including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma, etc. Minimum of 5 years Quality Assurance supervisory experience required Quality inspection, auditing and testing experience Experience with implementation of corrective action programs Strong computer skills including Microsoft Office, QMS applications and databases Knowledge of tools, concepts and methodologies of Quality Oversight Knowledge of relevant regulatory requirements AAP/EEO Statement Pisgah Labs, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

Job Type:

Full-time Pay:

From $85,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Relocation assistance Vision insurance

Education:

Master's (Preferred)

Experience:

CGMP Quality Assurance:

5 years (Required)

Language:

English (Required) Shift availability: Day Shift (Preferred) Night Shift (Preferred) Overnight Shift (Preferred) Ability to

Relocate:

Pisgah Forest, NC 28768: Relocate with an employer provided relocation package (Required)

Work Location:

In person