Since 1919, G & W Laboratories has made a portfolio of pharmaceutical products trusted by America's healthcare institutions, pharmacists, and medical professionals.  We are a proud family-owned and operated company committed to the best in healthcare through the development, manufacture and marketing of Rx and OTC specialty pharmaceuticals.  To continue to achieve our business objectives, we need the support and contribution of high caliber employees.   We currently seek highly motivated and experienced employees to fill the roles of Quality Assurance Documentation Specialist and Quality Assurance Inspector on our Quality/Regulatory Team.

Responsibilities of the Documentation Specialist include:

• Administering and preparing hardcopy and electronic official documents, filing, retrieving, and distributing to appropriate departments as required.
• Managing the change control process including the routing, tracking, expediting, and auditing of various documents.
• Maintaining documents in compliance with cGMPs including validation reports, laboratory testing monographs, product specifications, Standard Operating Procedures (SOPs) and Change Request Authorizations (CRAs).
• Writing, auditing and maintaining SOPs.
• Working closely with Quality Assurance and other departments to resolve documentation issues and ensure compliance.
• Identify and present ongoing initiatives for continuous improvements to the organization’s quality and compliance process.

Responsibilities of the off-shift Inspector include:

• Inspect and promote GMP and SOP compliance in an FDA regulated pharmaceutical manufacturing environment, ensuring product integrity, safety and compliance with standards.
• Sample and inspect raw materials, in-process and finished goods, packaging and labeling.
• Inspect, clear and release manufacturing rooms and packaging lines.
• Document procedures, record data and review records for completeness and accuracy to ensure compliance with SOPs and GMPs.
• Train and mentor new Quality Assurance Inspectors.
• Act as team leader on off-shift when QA supervision may not be present.
• Help to identify and present ongoing initiatives for continuous improvements to the organization’s quality process.

Qualifications and key competencies for these positions include:

• A BS/BA in a Life Science, Chemistry or related field required
• 5+ years related quality experience in a pharmaceutical manufacturing environment
• Extensive knowledge of cGMPs, current industry practices and FDA regulations
• Must be a highly organized and detail oriented self-starter with the appropriate computer skills
• Excellent verbal and written communication skills are required to produce accurate reports and interact successfully with all departments

We offer competitive salaries and benefits packages, in addition to our diverse and dynamic work environment.

Qualified candidates may please forward resumes, which must include salary history and/or requirements for consideration.

G&W Laboratories, Inc.

111 Coolidge St.

South Plainfield, NJ  07080

Fax:  908-753-1587

E-mail:  humanresources@gwlabs.com

www.gwlabs.com

Equal Opportunity Employer (m/f/d/v)

*No Phone Calls – Apply On-Line, Via E-mail or Via Fax