QA Associate

BCforward is currently seeking a highly motivated QA Associate in Winchester, KY 40391

Job Title: QA Associate

Duration: 3 Months (Temp-Hire)

Location: Winchester, KY 40391

Anticipated Start Date: ASAP

(Please note this is the target date and is subject to change. BCforward will send official notice ahead of a confirmed start date.)

Job Type: Contract (40 hrs. a week)

Pay Range: $20hr-$26.44/hr

(Please note that actual compensation may vary within this range due to factors such as location, experience, and job responsibilities, and does not encompass additional non-standard compensation (e.g., benefits, paid time off, per diem, etc.).

Work Schedule:

SUN-THURS - 10PM-6AM.

Job Description:

The QA Associate is responsible for the Quality support functions associated with the manufacturing of solid oral dosage products for a given business unit. The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and SOP) through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples.

II. Specific Tasks, Duties and Responsibilities:

RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:

Recommend SOP and batch record changes as needed

Review proposed SOP revisions and provide feedback to management

Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters

Perform room and equipment clearances per procedure following cleaning conducted by production.

Perform microbial swabbing of equipment and room surfaces for environmental monitoring.

Maintain a full understanding of all SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products.

Perform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-time.

Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations

that affect production real-time.

Works cross functionally to assess impact for potential deviations and assist in identifying if an investigation is required.

Initiate deviation problem reports in Trackwise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted.

Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards)

Other assignments as needed within the scope of QA Associate training curriculum.

Assist in investigations for deviations by supporting data gathering and root cause analysis

Enforcement of GMP Compliance.

Promotes team work and good communication.

Provide training and coaching to manufacturing staff as needed

Support site process improvements (training, efficiency projects, implementation of CAPAs)

Supports customer complaint investigation by performing inspection of retains and complaint samples

Essential Skills and Experience:

Education or Experience:

Bachelor’s Degree in related science or technical field preferred with 2 years prior work experience

Minimum of High School Diploma with 4 years of relevant experience in a regulated GMP manufacturing environment.

Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certification.

Knowledge/Skills Requirements:

Familiarity with basic laboratory instrumentation

Safe work habits

Basic math and computer skills

Good communication skills

Ability to follow written and verbal instructions

Able to work with limited supervision for routine tasks

Excellent documentation and handwriting skills

Proficient reading and comprehension skills

Sound decision-making, technical and problem-solving skills

Good time management skills

Expert technical writing and problem-solving skills

Good Laboratory Practices

Experienced with continuous improvement techniques

Benefits:

BCforward offers all eligible employees a comprehensive benefits package including, but not limited to major medical, HSA, dental, vision, employer-provided group life, voluntary life insurance, short-term disability, long-term disability, and 401k.

About BCforward:

Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward’s 6,000 consultants support more than 225 clients globally.

BCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class place to work.

BCforward is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

To learn more about how BCforward collects and uses personal information as part of the recruiting process, view our Privacy Notice and CCPA Addendum. As part of the recruitment process, we may ask for you to disclose and provide us with various categories of personal information, including identifiers, professional information, commercial information, education information, and other related information. BCforward will only use this information to complete the recruitment process.

This posting is not an offer of employment. All applicants applying for positions in the United States must be legally authorized to work in the United States. The submission of intentionally false or fraudulent information in response to this posting may render the applicant ineligible for the position. Any subsequent offer of employment will be considered employment at-will regardless of the anticipated assignment duration.

Job Types: Full-time, Temp-to-hire

Pay: $25.00 - $26.44 per hour

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Night shift

Work Location: In person

Salary : $25 - $26